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P03 - Incidence Rates of Non-Neoplastic Lesions (Rats)

 NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03

Study Type: SUBCHRON 90-DAY                                     ESTRAGOLE                                         Date: 10/08/03

Route: GAVAGE                                                                                                     Time: 10:29:06



                                                           FINAL/MICE









       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



                                                              Page   1





NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

Study Type: SUBCHRON 90-DAY                                     ESTRAGOLE                                         Date: 10/08/03    

Route: GAVAGE                                                                                                     Time: 10:29:06    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         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 (30%)      6 (60%)     10 (100%)    10 (100%)    

      Cholangiofibrosis                                                                                                 1 (10%)     

      Clear Cell Focus                                                                                                  1 (10%)     

      Eosinophilic Focus                                                                                               10 (100%)    

      Hepatodiaphragmatic Nodule                       2 (20%)      2 (20%)      2 (20%)      1 (10%)      2 (20%)                  

      Inflammation, Chronic                            4 (40%)      4 (40%)      5 (50%)      6 (60%)      3 (30%)                  

      Mixed Cell Focus                                                           1 (10%)      6 (60%)     10 (100%)    10 (100%)    

      Bile Duct, Hyperplasia                                       10 (100%)    10 (100%)    10 (100%)    10 (100%)    10 (100%)    

      Hepatocyte, Hypertrophy                                                                10 (100%)    10 (100%)    10 (100%)    

      Oval Cell, Hyperplasia                                       10 (100%)    10 (100%)    10 (100%)    10 (100%)    10 (100%)    

      Periportal, Infiltration Cellular, Histiocyte                                          10 (100%)    10 (100%)    10 (100%)    

      Periportal, Inflammation, Chronic                             5 (50%)     10 (100%)    10 (100%)    10 (100%)    10 (100%)    

   Mesentery                                                                                 (1)                                    

      Accessory Spleen                                                                        1 (100%)                              

      Fat, Necrosis                                                                           1 (100%)                              

   Salivary Glands                                    (10)         (10)         (10)         (10)         (10)         (10)         

      Submandibular Gland, Cytoplasmic Alteration                               10 (100%)    10 (100%)    10 (100%)    10 (100%)    

   Stomach, Glandular                                 (10)         (10)         (10)         (10)         (10)         (10)         

      Mineralization                                                                          1 (10%)      2 (20%)                  

      Necrosis, Focal                                               1 (10%)                                                         

      Epithelium, Glands, Atrophy                                                             8 (80%)     10 (100%)    10 (100%)    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 CARDIOVASCULAR SYSTEM                                                                                                              

                                                                                                                                    

   Heart                                              (10)                                                             (10)         

      Infiltration Cellular, Mononuclear Cell                                                                           1 (10%)     

      Myocardium, Infiltration Cellular,                                                                                            

        Mononuclear Cell                               2 (20%)                                                          2 (20%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                                                                                                    

                                                                                                                                    

                                                             Page    2                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

Study Type: SUBCHRON 90-DAY                                     ESTRAGOLE                                         Date: 10/08/03    

Route: GAVAGE                                                                                                     Time: 10:29:06    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         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 (30%)                                                                      

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 HEMATOPOIETIC SYSTEM                                                                                                               

                                                                                                                                    

   Bone Marrow                                        (10)                                                             (10)         

      Hyperplasia                                      1 (10%)                                                                      

   Lymph Node                                                                                                          (4)          

      Pancreatic, Hyperplasia, Lymphoid                                                                                 4 (100%)    

      Pancreatic, Infiltration Cellular, Histiocyte                                                                     4 (100%)    

   Lymph Node, Mesenteric                             (10)         (10)         (10)         (10)         (10)         (10)         

      Hyperplasia, Lymphoid                                                                                             3 (30%)     

      Infiltration Cellular, Histiocyte                                                       1 (10%)                   1 (10%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 INTEGUMENTARY SYSTEM                                                                                                               

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 MUSCULOSKELETAL SYSTEM                                                                                                             

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 NERVOUS SYSTEM                                                                                                                     

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                                                                                                    

                                                             Page    3                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

Study Type: SUBCHRON 90-DAY                                     ESTRAGOLE                                         Date: 10/08/03    

Route: GAVAGE                                                                                                     Time: 10:29:06    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         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 (50%)      6 (60%)      3 (30%)      4 (40%)      8 (80%)     10 (100%)    

      Bronchiole, Bronchus, Hyperplasia, Lymphoid                                1 (10%)                                            

   Nose                                               (10)         (10)         (10)         (10)         (10)         (10)         

      Olfactory Epithelium, Degeneration                                         1 (10%)      2 (20%)     10 (100%)    10 (100%)    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 SPECIAL SENSES SYSTEM                                                                                                              

                                                                                                                                    

   Harderian Gland                                    (10)                                                             (10)         

      Hyperplasia, Focal                                                                                                1 (10%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 URINARY SYSTEM                                                                                                                     

                                                                                                                                    

   Kidney                                             (10)         (10)         (10)         (10)         (10)         (10)         

      Infiltration Cellular, Lymphocyte                                                                    1 (10%)      3 (30%)     

      Cortex, Renal Tubule, Mineralization             2 (20%)      1 (10%)      4 (40%)      4 (40%)      1 (10%)      1 (10%)     

      Medulla, Renal Tubule, Mineralization                                                                1 (10%)                  

      Papilla, Renal Tubule, Mineralization            3 (30%)      4 (40%)      6 (60%)      7 (70%)      9 (90%)      7 (70%)     

      Renal Tubule, Regeneration                       1 (10%)      2 (20%)      1 (10%)      1 (10%)      3 (30%)      6 (60%)     

      Renal Tubule, Epithelium, Regeneration                                     1 (10%)                                            

                                                                                                                                    

                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                                                                                                    

     
                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                             Page    4                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

Study Type: SUBCHRON 90-DAY                                     ESTRAGOLE                                         Date: 10/08/03    

Route: GAVAGE                                                                                                     Time: 10:29:06    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         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 (10%)     

   Intestine Large, Rectum                            (10)                                                             (10)         

      Parasite Metazoan                                1 (10%)                                                                      

   Liver                                              (10)         (10)         (10)         (10)         (10)         (10)         

      Angiectasis, Focal                                                                                   2 (20%)                  

      Basophilic Focus                                                                        6 (60%)      9 (90%)      6 (60%)     

      Cholangiofibrosis                                                                                                10 (100%)    

      Clear Cell Focus                                                                        3 (30%)      1 (10%)      1 (10%)     

      Eosinophilic Focus                                                                      1 (10%)     10 (100%)    10 (100%)    

      Hepatodiaphragmatic Nodule                       1 (10%)      3 (30%)                   1 (10%)      3 (30%)                  

      Inflammation, Chronic                            1 (10%)      2 (20%)      1 (10%)      1 (10%)      3 (30%)                  

      Mixed Cell Focus                                                           1 (10%)      9 (90%)     10 (100%)     8 (80%)     

      Bile Duct, Hyperplasia                                       10 (100%)    10 (100%)    10 (100%)    10 (100%)    10 (100%)    

      Centrilobular, Vacuolization Cytoplasmic         1 (10%)                                                                      

      Hepatocyte, Hypertrophy                                                   10 (100%)    10 (100%)    10 (100%)    10 (100%)    

      Oval Cell, Hyperplasia                                       10 (100%)    10 (100%)    10 (100%)    10 (100%)    10 (100%)    

      Periportal, Infiltration Cellular, Histiocyte                10 (100%)    10 (100%)    10 (100%)    10 (100%)    10 (100%)    

      Periportal, Inflammation, Chronic                            10 (100%)    10 (100%)    10 (100%)    10 (100%)    10 (100%)    

   Pancreas                                           (10)                                                             (10)         

      Acinus, Atrophy                                                                                                   1 (10%)     

   Salivary Glands                                    (10)         (10)         (10)         (10)         (10)         (10)         

      Submandibular Gland, Cytoplasmic Alteration                               10 (100%)    10 (100%)    10 (100%)    10 (100%)    

   Stomach, Glandular                                 (10)         (10)         (10)         (10)         (10)         (10)         

      Mineralization                                                                          1 (10%)                               

      Epithelium, Glands, Atrophy                                                2 (20%)     10 (100%)    10 (100%)    10 (100%)    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 CARDIOVASCULAR SYSTEM                                                                                                              

                                                                                                                                    

   Heart                                              (10)                                                             (10)         

      Infiltration Cellular, Mononuclear Cell          2 (20%)                                                          3 (30%)     

                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                                                                                                    

                                                             Page    5                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

Study Type: SUBCHRON 90-DAY                                     ESTRAGOLE                                         Date: 10/08/03    

Route: GAVAGE                                                                                                     Time: 10:29:06    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         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 (60%)                                                          3 (30%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 ENDOCRINE SYSTEM                                                                                                                   

                                                                                                                                    

   Pituitary Gland                                    (10)         (10)         (10)         (10)         (10)         (10)         

      Pars Distalis, Chromophobe Cell, Hypertrophy                                                        10 (100%)    10 (100%)    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 GENERAL BODY SYSTEM                                                                                                                

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 GENITAL SYSTEM                                                                                                                     

                                                                                                                                    

   Epididymis                                         (10)         (10)         (10)         (10)         (10)         (10)         

      Hypospermia                                      1 (10%)                                                                      

      Bilateral, Hypospermia                                                                              10 (100%)    10 (100%)    

   Testes                                             (10)         (10)         (10)         (10)         (10)         (10)         

      Bilateral, Germinal Epithelium, Degeneration                                                        10 (100%)    10 (100%)    

      Germinal Epithelium, Degeneration                1 (10%)                                2 (20%)                               

      Germinal Epithelium, Mineralization                                                     1 (10%)                               

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 HEMATOPOIETIC SYSTEM                                                                                                               

                                                                                                                                    

   Bone Marrow                                        (10)         (10)         (10)         (10)         (10)         (10)         

      Hyperplasia                                                                4 (40%)      3 (30%)     10 (100%)    10 (100%)    

   Lymph Node                                                                                             (3)          (3)          

      Pancreatic, Hyperplasia, Lymphoid                                                                    2 (67%)      3 (100%)    

      Pancreatic, Infiltration Cellular, Histiocyte                                                        3 (100%)     3 (100%)    

   Lymph Node, Mesenteric                             (10)         (10)         (10)         (10)         (7)          (10)         

      Hyperplasia, Lymphoid                                         1 (10%)                                2 (29%)      2 (20%)     

      Infiltration Cellular, Histiocyte                                                       1 (10%)      1 (14%)      1 (10%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 INTEGUMENTARY SYSTEM                                                                                                               

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                                                                                                    

                                                                                                                                    

                                                             Page    6                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-01         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

Study Type: SUBCHRON 90-DAY                                     ESTRAGOLE                                         Date: 10/08/03    

Route: GAVAGE                                                                                                     Time: 10:29:06    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         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 (50%)      3 (30%)      6 (60%)      7 (70%)      6 (60%)      8 (80%)     

      Inflammation, Granulomatous                                   1 (10%)                                4 (40%)                  

   Nose                                               (10)         (10)         (10)         (10)         (10)         (10)         

      Inflammation, Chronic                                                                   2 (20%)                               

      Olfactory Epithelium, Degeneration                                                                   9 (90%)     10 (100%)    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 SPECIAL SENSES SYSTEM                                                                                                              

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 URINARY SYSTEM                                                                                                                     

                                                                                                                                    

   Kidney                                             (10)         (10)         (10)         (10)         (10)         (10)         

      Infiltration Cellular, Lymphocyte                1 (10%)                   1 (10%)      2 (20%)      7 (70%)                  

      Cortex, Renal Tubule, Pigmentation                                                     10 (100%)    10 (100%)    10 (100%)    

      Medulla, Renal Tubule, Mineralization                                      1 (10%)                                            

      Papilla, Renal Tubule, Mineralization            4 (40%)      2 (20%)      2 (20%)      8 (80%)     10 (100%)    10 (100%)    

      Renal Tubule, Cyst                                                         1 (10%)                                            

      Renal Tubule, Regeneration                       7 (70%)      7 (70%)     10 (100%)    10 (100%)    10 (100%)     8 (80%)     

                                                                                                                                    

                                                                                                                                    

a  Number of animals examined microscopically at site and number of animals with lesion                                             

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                             Page    7                                                              

                                                                                                                                   

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                             ----------              END OF REPORT             ----------                                           

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