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

NTP Experiment-Test: 60946-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03

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

Route: GAVAGE                                                                                                     Time: 07:58:21



                                                           FINAL/MICE









       Facility:  Battelle Columbus Laboratory



       Chemical CAS #:  140-67-0



       Lock Date:  05/28/02



       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: 60946-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

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

Route: GAVAGE                                                                                                     Time: 07:58:21    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         B6C3F1 MICE 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                                                                                                                      

    Natural Death                                                                                                       8           

    Moribund Sacrifice                                                                                                  2           

  Survivors                                                                                                                         

    Terminal Sacrifice                                10           10           10           10           10                        

                                                                                                                                    

  Animals Examined Microscopically                    10           10           10           10           10           10           

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 ALIMENTARY SYSTEM                                                                                                                  

                                                                                                                                    

   Esophagus                                          (10)                                                (10)         (10)         

      Muscularis, Degeneration                                                                             1 (10%)                  

   Gallbladder                                        (10)                                                (10)         (10)         

      Inflammation                                                                                                      1 (10%)     

   Intestine Large, Colon                             (10)                                                (10)         (10)         

      Inflammation                                                                                                      1 (10%)     

   Intestine Large, Cecum                             (10)                                                (10)         (10)         

      Inflammation                                                                                                      1 (10%)     

      Goblet Cell, Hyperplasia                                                                             1 (10%)                  

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

      Basophilic Focus                                                                                     1 (10%)                  

      Eosinophilic Focus                                                                                   1 (10%)                  

      Fatty Change, Diffuse                                                                                             5 (50%)     

      Inflammation, Chronic Active                    10 (100%)     9 (90%)     10 (100%)    10 (100%)    10 (100%)     2 (20%)     

      Mixed Cell Focus                                                                        1 (10%)                               

      Necrosis                                                                                                         10 (100%)    

      Pigmentation, Hemosiderin                        1 (10%)                                                                      

      Bile Duct, Hyperplasia                                                                  1 (10%)      2 (20%)                  

      Hepatocyte, Degeneration                                      1 (10%)      3 (30%)     10 (100%)    10 (100%)                 

      Hepatocyte, Hypertrophy                                                    3 (30%)     10 (100%)    10 (100%)                 

      Oval Cell, Hyperplasia                                        1 (10%)     10 (100%)    10 (100%)    10 (100%)     5 (50%)     

   Mesentery                                                                                                           (2)          

      Fat, Inflammation                                                                                                 1 (50%)     

      Fat, Necrosis                                                                                                     1 (50%)     

   Salivary Glands                                    (10)                                                (10)         (10)         

      Cytoplasmic Alteration                                                                                           10 (100%)    

   Stomach, Forestomach                               (10)         (10)         (10)         (9)          (10)         (10)         

      Hyperplasia, Squamous                                                                                             6 (60%)     

      Mineralization                                                                                                    6 (60%)     

      Ulcer                                                                                                             6 (60%)     

                                                                                                                                    

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

                                                                                                                                    

                                                             Page    2                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

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

Route: GAVAGE                                                                                                     Time: 07:58:21    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         B6C3F1 MICE FEMALE                        0 MG/KG      37.5         75           150          300          600             

                                                                MG/KG        MG/KG        MG/KG        MG/KG        MG/KG           

____________________________________________________________________________________________________________________________________

                                                                                                                                    

ALIMENTARY SYSTEM - CONT                                                                                                            

      Epithelium, Necrosis                                                                                              1 (10%)     

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

      Atrophy                                                                                              1 (10%)                  

      Infiltration Cellular, Polymorphonuclear                                                             1 (10%)                  

      Mineralization                                                                          1 (10%)      2 (20%)                  

      Epithelium, Glands, Degeneration                                                                     1 (10%)      5 (50%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 CARDIOVASCULAR SYSTEM                                                                                                              

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 ENDOCRINE SYSTEM                                                                                                                   

                                                                                                                                    

   Adrenal Cortex                                     (10)                                                (10)         (10)         

      Subcapsular, Hyperplasia                        10 (100%)                                           10 (100%)     6 (60%)     

   Parathyroid Gland                                  (7)                                                 (8)          (8)          

      Cyst                                             1 (14%)                                                                      

   Thyroid Gland                                      (10)                                                (10)         (10)         

      Infiltration Cellular, Lymphocyte                                                                    1 (10%)                  

      Follicle, Cyst                                                                                       1 (10%)                  

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 GENERAL BODY SYSTEM                                                                                                                

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 GENITAL SYSTEM                                                                                                                     

                                                                                                                                    

   Clitoral Gland                                     (10)                                   (1)          (10)         (10)         

      Pigmentation, Melanin                                                                   1 (100%)                              

   Uterus                                             (10)                                                (10)         (10)         

      Endometrium, Hyperplasia, Cystic                 1 (10%)                                             1 (10%)                  

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 HEMATOPOIETIC SYSTEM                                                                                                               

                                                                                                                                    

   Lymph Node                                                                                                          (3)          

      Mediastinal, Atrophy                                                                                              1 (33%)     

      Mediastinal, Infiltration Cellular,                                                                                           

        Histiocyte                                                                                                      1 (33%)     

                                                                                                                                    

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

                                                                                                                                    

                                                             Page    3                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

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

Route: GAVAGE                                                                                                     Time: 07:58:21    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         B6C3F1 MICE FEMALE                        0 MG/KG      37.5         75           150          300          600             

                                                                MG/KG        MG/KG        MG/KG        MG/KG        MG/KG           

____________________________________________________________________________________________________________________________________

                                                                                                                                    

HEMATOPOIETIC SYSTEM - CONT                                                                                                         

      Pancreatic, Atrophy                                                                                               1 (33%)     

      Renal, Atrophy                                                                                                    1 (33%)     

   Lymph Node, Mandibular                             (10)         (9)          (9)          (10)         (9)          (8)          

      Atrophy                                                                                                           7 (88%)     

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

      Atrophy                                                                                                           9 (90%)     

      Infiltration Cellular, Polymorphonuclear                                                                          1 (10%)     

   Spleen                                             (10)         (10)         (10)         (10)         (10)         (10)         

      Hematopoietic Cell Proliferation                10 (100%)    10 (100%)    10 (100%)    10 (100%)    10 (100%)     2 (20%)     

      Lymphoid Follicle, Atrophy                                                                                       10 (100%)    

      Red Pulp, Depletion Cellular                                                                                      9 (90%)     

   Thymus                                             (10)                                                (10)         (10)         

      Necrosis, Lymphoid                                                                                               10 (100%)    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 INTEGUMENTARY SYSTEM                                                                                                               

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 MUSCULOSKELETAL SYSTEM                                                                                                             

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 NERVOUS SYSTEM                                                                                                                     

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 RESPIRATORY SYSTEM                                                                                                                 

                                                                                                                                    

   Lung                                               (10)                                                (10)         (10)         

      Congestion                                                                                                        1 (10%)     

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

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

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 SPECIAL SENSES SYSTEM                                                                                                              

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

                                                                                                                                    

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

                                                                                                                                    

                                                             Page    4                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

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

Route: GAVAGE                                                                                                     Time: 07:58:21    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         B6C3F1 MICE FEMALE                        0 MG/KG      37.5         75           150          300          600             

                                                                MG/KG        MG/KG        MG/KG        MG/KG        MG/KG           

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 URINARY SYSTEM                                                                                                                     

                                                                                                                                    

   Kidney                                             (10)         (9)          (9)          (10)         (10)         (10)         

      Nephropathy                                      5 (50%)                                             1 (10%)      1 (10%)     

      Papilla, Mineralization                                                                              1 (10%)                  

   Urinary Bladder                                    (10)                                                (10)         (10)         

      Infiltration Cellular, Mononuclear Cell                                                              1 (10%)                  

                                                                                                                                    

                                                                                                                                    

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

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                             Page    5                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

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

Route: GAVAGE                                                                                                     Time: 07:58:21    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         B6C3F1 MICE 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                                                                                                                      

    Moribund Sacrifice                                                                                                  1           

  Survivors                                                                                                                         

    Terminal Sacrifice                                10           10           10           10           10            9           

                                                                                                                                    

  Animals Examined Microscopically                    10           10           10           10           10           10           

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 ALIMENTARY SYSTEM                                                                                                                  

                                                                                                                                    

   Gallbladder                                        (10)                                                             (10)         

      Infiltration Cellular, Mixed Cell                1 (10%)                                                                      

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

      Eosinophilic Focus                                                                                                1 (10%)     

      Hematopoietic Cell Proliferation                 1 (10%)                                                                      

      Inflammation, Chronic Active                     2 (20%)      2 (20%)      4 (40%)      4 (40%)      7 (70%)      7 (70%)     

      Hepatocyte, Degeneration                                                                             5 (50%)     10 (100%)    

      Hepatocyte, Hypertrophy                                                                              8 (80%)     10 (100%)    

      Oval Cell, Hyperplasia                                                                              10 (100%)     9 (90%)     

   Salivary Glands                                    (10)                                                (10)         (10)         

      Cytoplasmic Alteration                                                                                            1 (10%)     

   Stomach, Forestomach                               (10)         (10)         (10)         (10)         (10)         (10)         

      Hyperplasia, Squamous                                                                                             1 (10%)     

      Inflammation                                                                                                      1 (10%)     

      Mineralization                                   1 (10%)                                                                      

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

      Dilatation                                                    1 (10%)                                                         

      Infiltration Cellular, Polymorphonuclear         3 (30%)                                                                      

      Mineralization                                                                                       1 (10%)                  

      Epithelium, Glands, Atrophy                                                                                       1 (10%)     

      Epithelium, Glands, Degeneration                                                                                  1 (10%)     

      Glands, Ectasia                                                                                                   1 (10%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 CARDIOVASCULAR SYSTEM                                                                                                              

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 ENDOCRINE SYSTEM                                                                                                                   

                                                                                                                                    

                                                                                                                                    

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

                                                                                                                                    

                                                             Page    6                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

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

Route: GAVAGE                                                                                                     Time: 07:58:21    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         B6C3F1 MICE MALE                          0 MG/KG      37.5         75           150          300          600             

                                                                MG/KG        MG/KG        MG/KG        MG/KG        MG/KG           

____________________________________________________________________________________________________________________________________

                                                                                                                                    

ENDOCRINE SYSTEM - CONT                                                                                                             

   Adrenal Cortex                                     (10)                                                             (10)         

      Subcapsular, Hyperplasia                         5 (50%)                                                          6 (60%)     

   Parathyroid Gland                                  (10)                                                             (8)          

      Cyst                                                                                                              1 (13%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 GENERAL BODY SYSTEM                                                                                                                

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 GENITAL SYSTEM                                                                                                                     

                                                                                                                                    

   Preputial Gland                                    (10)                                                             (10)         

      Atrophy                                                                                                           1 (10%)     

      Ectasia                                          1 (10%)                                                                      

   Seminal Vesicle                                    (10)                                                             (10)         

      Atrophy                                                                                                           1 (10%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 HEMATOPOIETIC SYSTEM                                                                                                               

                                                                                                                                    

   Bone Marrow                                        (10)                                                             (10)         

      Atrophy                                                                                                           1 (10%)     

   Lymph Node, Mandibular                             (10)         (10)         (10)         (10)         (10)         (10)         

      Atrophy                                                                                                           1 (10%)     

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

      Atrophy                                                                                                           1 (10%)     

   Spleen                                             (10)         (10)         (10)         (10)         (10)         (10)         

      Hematopoietic Cell Proliferation                10 (100%)    10 (100%)    10 (100%)    10 (100%)    10 (100%)     8 (80%)     

      Lymphoid Follicle, Atrophy                                                                                        1 (10%)     

   Thymus                                             (10)                                                             (10)         

      Atrophy                                                                                                           1 (10%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 INTEGUMENTARY SYSTEM                                                                                                               

                                                                                                                                    

   None                                                                                                                             

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 MUSCULOSKELETAL SYSTEM                                                                                                             

                                                                                                                                    

   None                                                                                                                             

                                                                                                                                    

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

                                                                                                                                    

                                                             Page    7                                                              

                                                                                                                                   

NTP Experiment-Test: 60946-02         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  

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

Route: GAVAGE                                                                                                     Time: 07:58:21    

____________________________________________________________________________________________________________________________________

                                                                                                                                    

         B6C3F1 MICE MALE                          0 MG/KG      37.5         75           150          300          600             

                                                                MG/KG        MG/KG        MG/KG        MG/KG        MG/KG           

____________________________________________________________________________________________________________________________________

                                                                                                                                    

                                                                                                                                    

 NERVOUS SYSTEM                                                                                                                     

                                                                                                                                    

   Brain                                              (10)                                                             (10)         

      Venule, Infiltration Cellular, Mixed Cell                                                                         1 (10%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 RESPIRATORY SYSTEM                                                                                                                 

                                                                                                                                    

   Lung                                               (10)                                                             (10)         

      Congestion, Diffuse                                                                                               1 (10%)     

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

      Inflammation                                                                                                      1 (10%)     

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

   Trachea                                            (10)                                                             (10)         

      Inflammation                                     1 (10%)                                                                      

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 SPECIAL SENSES SYSTEM                                                                                                              

                                                                                                                                    

   Harderian Gland                                    (10)                                                             (10)         

      Infiltration Cellular, Mononuclear Cell                                                                           1 (10%)     

____________________________________________________________________________________________________________________________________

                                                                                                                                    

 URINARY SYSTEM                                                                                                                     

                                                                                                                                    

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

      Nephropathy                                      3 (30%)      5 (50%)      2 (20%)      4 (40%)      4 (40%)      2 (20%)     

      Papilla, Mineralization                          1 (10%)                   1 (10%)                   1 (10%)                  

      Renal Tubule, Vacuolization Cytoplasmic          9 (90%)      9 (90%)      2 (20%)      1 (10%)                               

   Urinary Bladder                                    (10)                                                             (10)         

      Infiltration Cellular, Mononuclear Cell                                                                           1 (10%)     

      Inflammation                                     1 (10%)                                                                      

                                                                                                                                    

                                                                                                                                    

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

  
                                                                                                                                    

                                                                                                                                    

                                                                                                                                    

                                                             Page    8                                                              

                                                                                                                                   

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

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