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TDMS Study 05161-06 Pathology Tables

NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02

                                                            FINAL#2




       Facility:  Southern Research Institute

       Chemical CAS #:  23246-96-0

       Lock Date:  11/17/99

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include All

































a  Number of animals examined microscopically at site and number of animals with lesion
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)

                                                              Page   1


NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                           0            3.0                                                              
                                                      MG/KG/DY     MG/KG/DY                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          50           50                                                               
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 9           25                                                               
    Natural Death                                      3            8                                                               
    Accidently Killed                                  4                                                                            
  Survivors                                                                                                                         
    Natural Death                                                   1                                                               
    Terminal Sacrifice                                34           16                                                               
                                                                                                                                    
  Animals Examined Microscopically                    50           50                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Gallbladder                                        (45)         (45)                                                             
      Cyst                                             1 [1.0]      2 [1.5]                                                         
      Epithelium, Cytoplasmic Alteration                            1 [3.0]                                                         
   Intestine Large, Colon                             (49)         (47)                                                             
      Epithelium, Hyperplasia, Focal                                1 [2.0]                                                         
   Intestine Large, Rectum                            (48)         (47)                                                             
      Inflammation, Chronic, Focal                                  1 [1.0]                                                         
   Intestine Large, Cecum                             (48)         (47)                                                             
      Edema                                                         5 [3.0]                                                         
      Fibrosis                                         1 [1.0]                                                                      
      Hemorrhage, Focal                                             6 [2.3]                                                         
      Artery, Inflammation, Chronic, Focal                         18 [1.7]                                                         
      Epithelium, Erosion, Focal                                    6 [1.8]                                                         
   Intestine Small, Duodenum                          (47)         (46)                                                             
      Hemorrhage, Focal                                             2 [2.5]                                                         
      Necrosis, Focal                                               2 [3.0]                                                         
      Artery, Inflammation, Chronic                                13 [1.9]                                                         
   Intestine Small, Ileum                             (46)         (46)                                                             
      Epithelium, Cyst                                 1 [2.0]                                                                      
      Peyer's Patch, Hyperplasia, Lymphoid                          1 [3.0]                                                         
   Liver                                              (49)         (50)                                                             
      Angiectasis                                      2 [2.0]      2 [2.0]                                                         
      Clear Cell Focus                                 1                                                                            
      Congestion, Focal                                             1 [2.0]                                                         
      Cyst                                                          1 [2.0]                                                         
      Eosinophilic Focus                               2                                                                            
      Fibrosis, Focal                                               2 [2.0]                                                         
      Hemorrhage, Focal                                             2 [2.5]                                                         
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                           0            3.0                                                              
                                                      MG/KG/DY     MG/KG/DY                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Hyperplasia, Focal, Lymphoid                     2 [2.0]                                                                      
      Infarct                                                       1 [3.0]                                                         
      Infiltration Cellular, Mixed Cell               29 [1.4]     41 [1.8]                                                         
      Inflammation, Focal, Suppurative                 1 [2.0]                                                                      
      Mineralization, Focal                            1 [1.0]                                                                      
      Pigmentation, Focal                                           1 [2.0]                                                         
      Thrombosis                                                    1 [2.0]                                                         
      Artery, Inflammation, Chronic                                 1 [1.0]                                                         
      Bile Duct, Hyperplasia                                       28 [1.9]                                                         
      Endothelial Cell, Hyperplasia, Focal                          1 [3.0]                                                         
      Hepatocyte, Cytomegaly                                       49 [2.3]                                                         
      Hepatocyte, Karyomegaly                                      49 [2.3]                                                         
      Hepatocyte, Mixed Cell Focus                     1 [2.0]                                                                      
      Hepatocyte, Necrosis, Focal                     12 [1.3]     19 [1.5]                                                         
      Hepatocyte, Vacuolization Cytoplasmic,                                                                                        
          Diffuse                                      8 [3.0]      1 [3.0]                                                         
      Hepatocyte, Vacuolization Cytoplasmic, Focal     3 [1.7]                                                                      
      Hepatocyte, Centrilobular, Necrosis                           1 [3.0]                                                         
      Hepatocyte, Centrilobular, Vacuolization                                                                                      
          Cytoplasmic                                               3 [2.7]                                                         
      Hepatocyte, Midzonal, Vacuolization                                                                                           
          Cytoplasmic                                  1 [3.0]      3 [2.0]                                                         
   Mesentery                                          (23)         (29)                                                             
      Fibrosis, Focal                                               2 [3.0]                                                         
      Hemorrhage                                                    1 [3.0]                                                         
      Inflammation, Chronic                                         2 [2.5]                                                         
      Inflammation, Chronic, Focal, Suppurative                     1 [2.0]                                                         
      Inflammation, Suppurative                                     1 [4.0]                                                         
      Artery, Inflammation, Chronic, Focal             1 [3.0]     19 [2.5]                                                         
      Artery, Mineralization, Focal                                 1 [2.0]                                                         
      Fat, Necrosis                                   19 [2.5]      2 [1.0]                                                         
   Pancreas                                           (49)         (50)                                                             
      Amyloid Deposition                               1 [3.0]                                                                      
      Atrophy, Focal                                   1 [3.0]                                                                      
      Fibrosis, Focal                                               1 [3.0]                                                         
      Necrosis, Focal                                               1 [2.0]                                                         
      Acinus, Atrophy, Diffuse                                      1 [4.0]                                                         
      Acinus, Atrophy, Focal                                        1 [1.0]                                                         
      Artery, Inflammation, Chronic                                 3 [1.3]                                                         
   Salivary Glands                                    (50)         (50)                                                             
      Artery, Inflammation, Chronic                    1 [3.0]      2 [2.5]                                                         
   Stomach, Forestomach                               (49)         (49)                                                             
      Inflammation, Focal                              2 [2.0]                                                                      
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                           0            3.0                                                              
                                                      MG/KG/DY     MG/KG/DY                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Ulcer                                            1 [2.0]                                                                      
      Epithelium, Cyst                                 1 [1.0]                                                                      
      Epithelium, Hyperplasia                          1 [3.0]                                                                      
   Stomach, Glandular                                 (49)         (48)                                                             
      Cyst                                                          2 [2.0]                                                         
   Tooth                                              (7)                                                                           
      Malformation                                     1 [2.0]                                                                      
      Peridontal Tissue, Inflammation, Chronic         6 [1.8]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                                    (2)                                                              
      Inflammation, Chronic                                         1 [3.0]                                                         
      Aorta, Mineralization                                         1 [3.0]                                                         
   Heart                                              (50)         (50)                                                             
      Infiltration Cellular, Mixed Cell                3 [1.7]      6 [1.7]                                                         
      Inflammation, Chronic, Focal                                  2 [2.0]                                                         
      Mineralization, Focal                                         4 [2.3]                                                         
      Epicardium, Infiltration Cellular, Mixed Cell                 1 [3.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)                                                             
      Accessory Adrenal Cortical Nodule                             2 [1.0]                                                         
      Angiectasis                                                   1 [4.0]                                                         
      Cyst                                             1 [1.0]                                                                      
      Cytoplasmic Alteration                                        1 [2.0]                                                         
      Cytoplasmic Alteration, Focal                    1           25                                                               
      Inflammation, Chronic, Focal                                  6 [2.2]                                                         
      Thrombosis                                                    1 [3.0]                                                         
      Bilateral, Hypertrophy, Focal                    1 [3.0]                                                                      
      Capsule, Fibrosis, Focal                                      1 [2.0]                                                         
   Adrenal Medulla                                    (49)         (49)                                                             
      Atypia Cellular                                  1 [2.0]                                                                      
      Hyperplasia                                                   1 [2.0]                                                         
   Parathyroid Gland                                  (47)         (46)                                                             
      Cyst                                             1 [2.0]      1 [2.0]                                                         
   Pituitary Gland                                    (48)         (49)                                                             
      Angiectasis                                      4 [2.5]      1 [2.0]                                                         
      Pars Distalis, Cytoplasmic Alteration, Focal     3 [2.0]      3 [1.3]                                                         
      Pars Distalis, Hemorrhage, Focal                              1 [2.0]                                                         
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    4                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                           0            3.0                                                              
                                                      MG/KG/DY     MG/KG/DY                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Pars Distalis, Hyperplasia, Focal                1 [2.0]                                                                      
      Rathke's Cleft, Cyst                             1 [2.0]                                                                      
   Thyroid Gland                                      (49)         (50)                                                             
      Degeneration, Cystic, Focal                     13 [1.8]     21 [1.9]                                                         
      Inflammation, Chronic, Focal                     1 [1.0]      2 [1.5]                                                         
      Follicle, Cyst                                   1 [2.0]                                                                      
      Follicular Cell, Cytoplasmic Alteration,                                                                                      
           Diffuse                                                  1 [3.0]                                                         
      Follicular Cell, Hyperplasia                     1 [3.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                      (1)                                                              
      Abdominal, Inflammation                                       1 [4.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (49)         (49)                                                             
      Degeneration, Cystic                                          2 [2.5]                                                         
      Inflammation, Chronic                            1 [2.0]                                                                      
   Ovary                                              (49)         (48)                                                             
      Angiectasis                                      3 [2.7]      1 [3.0]                                                         
      Cyst                                            15 [2.6]     15 [2.5]                                                         
      Cyst, Multiple                                                2 [2.5]                                                         
      Hemorrhage                                       1 [2.0]      1 [3.0]                                                         
      Inflammation, Suppurative                                     1 [4.0]                                                         
      Mineralization                                   1 [1.0]                                                                      
      Pigmentation, Focal                              1 [2.0]                                                                      
      Thrombosis                                                    1 [2.0]                                                         
      Artery, Inflammation, Chronic                                26 [2.6]                                                         
      Bilateral, Cyst                                  1 [3.0]      2 [2.5]                                                         
      Interstitial Cell, Hyperplasia                   1 [3.0]      1 [3.0]                                                         
   Uterus                                             (49)         (50)                                                             
      Angiectasis                                      1 [3.0]      2 [2.0]                                                         
      Cyst                                                          1 [3.0]                                                         
      Hemorrhage                                                    1 [3.0]                                                         
      Hydrometra                                      27 [3.0]     19 [2.7]                                                         
      Inflammation, Suppurative                        2 [2.5]                                                                      
      Artery, Inflammation                                          2 [3.0]                                                         
      Artery, Inflammation, Chronic, Focal                         21 [2.4]                                                         
      Endometrium, Hyperplasia, Cystic                43 [2.9]     41 [2.8]                                                         
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                           0            3.0                                                              
                                                      MG/KG/DY     MG/KG/DY                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)                                                             
      Hyperplasia                                      2 [3.5]      6 [3.0]                                                         
   Lymph Node                                         (7)          (15)                                                             
      Hemorrhage                                                    1 [2.0]                                                         
      Hyperplasia, Histiocytic                                      1 [3.0]                                                         
      Hyperplasia, Lymphoid                            1 [2.0]                                                                      
      Bronchial, Hyperplasia, Lymphoid                              1 [2.0]                                                         
      Bronchial, Hyperplasia, Plasma Cell                           1 [3.0]                                                         
      Deep Cervical, Hyperplasia, Lymphoid                          1 [3.0]                                                         
      Iliac, Hemorrhage                                1 [3.0]                                                                      
      Iliac, Hyperplasia, Plasma Cell                               1 [4.0]                                                         
      Mediastinal, Hyperplasia, Lymphoid               1 [3.0]      1 [3.0]                                                         
      Mediastinal, Hyperplasia, Plasma Cell                         2 [3.0]                                                         
      Renal, Angiectasis                                            1 [4.0]                                                         
      Renal, Hemorrhage                                             2 [4.0]                                                         
      Renal, Hyperplasia, Plasma Cell                               1 [4.0]                                                         
      Renal, Inflammation, Suppurative                              1 [3.0]                                                         
   Lymph Node, Mandibular                             (48)         (47)                                                             
      Fibrosis                                                      1 [4.0]                                                         
      Hyperplasia, Lymphoid                            2 [3.0]      1 [2.0]                                                         
      Hyperplasia, Plasma Cell                         1 [3.0]      1 [3.0]                                                         
   Lymph Node, Mesenteric                             (48)         (49)                                                             
      Angiectasis                                                   1 [2.0]                                                         
      Fibrosis                                                      1 [4.0]                                                         
      Hematopoietic Cell Proliferation                              4 [2.5]                                                         
      Hemorrhage                                                    4 [2.5]                                                         
      Hyperplasia, Histiocytic                                      2 [3.0]                                                         
      Hyperplasia, Lymphoid                            2 [2.5]      2 [2.0]                                                         
      Hyperplasia, Plasma Cell                         3 [3.0]      1 [3.0]                                                         
      Artery, Inflammation, Chronic                                 1 [2.0]                                                         
   Spleen                                             (49)         (50)                                                             
      Fibrosis, Focal                                               1 [2.0]                                                         
      Hematopoietic Cell Proliferation                32 [2.6]     43 [3.1]                                                         
      Hyperplasia, Lymphoid                            9 [2.4]      4 [2.5]                                                         
      Hyperplasia, Plasma Cell                         1 [3.0]                                                                      
      Pigmentation                                     1 [2.0]                                                                      
      Artery, Inflammation, Chronic, Focal                          6 [2.0]                                                         
   Thymus                                             (49)         (39)                                                             
      Angiectasis                                      1 [3.0]                                                                      
      Atrophy                                                       2 [2.5]                                                         
      Cyst                                                          1 [2.0]                                                         
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                           0            3.0                                                              
                                                      MG/KG/DY     MG/KG/DY                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Hyperplasia, Histiocytic                                      1 [3.0]                                                         
      Hyperplasia, Lymphoid                            3 [2.3]                                                                      
      Artery, Inflammation, Chronic                                 1 [1.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (49)         (50)                                                             
      Ectasia                                                       2 [3.0]                                                         
   Skin                                               (50)         (50)                                                             
      Inflammation, Chronic, Focal                     1 [2.0]                                                                      
      Artery, Subcutaneous Tissue, Inflammation,                                                                                    
           Chronic                                                  1 [2.0]                                                         
      Dermis, Edema, Focal                                          1 [3.0]                                                         
      Subcutaneous Tissue, Edema                                    1 [3.0]                                                         
      Subcutaneous Tissue, Inflammation, Focal,                                                                                     
           Suppurative                                 1 [4.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)                                                             
      Cranium, Fibrous Osteodystrophy                               1 [2.0]                                                         
      Vertebra, Hyperostosis, Focal                   41 [3.0]     33 [2.9]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)                                                             
      Atrophy, Focal                                                1 [4.0]                                                         
      Gliosis                                                       1 [1.0]                                                         
      Hemorrhage, Focal                                             4 [2.0]                                                         
      Artery, Meninges, Inflammation, Chronic                       1 [3.0]                                                         
   Peripheral Nerve                                                (6)                                                              
      Spinal, Ganglion, Inflammation, Chronic                       1 [3.0]                                                         
   Spinal Cord                                                     (6)                                                              
      Hemorrhage, Focal                                             1 [1.0]                                                         
      Meninges, Inflammation, Chronic                               1 [2.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)                                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    7                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                           0            3.0                                                              
                                                      MG/KG/DY     MG/KG/DY                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Congestion                                       3 [1.3]      2 [3.0]                                                         
      Foreign Body                                     4 [2.5]                                                                      
      Hemorrhage                                       1 [2.0]      4 [2.3]                                                         
      Hyperplasia, Focal, Mast Cell                                 1 [2.0]                                                         
      Hyperplasia, Histiocytic                         2 [2.5]      9 [2.1]                                                         
      Hyperplasia, Lymphoid                            2 [2.0]                                                                      
      Infiltration Cellular, Mixed Cell                             3 [2.3]                                                         
      Pigmentation, Focal                              1 [2.0]                                                                      
      Alveolar Epithelium, Hyperplasia                 1 [1.0]      6 [1.5]                                                         
      Artery, Mediastinum, Inflammation, Chronic                    2 [2.0]                                                         
      Interstitium, Edema                              1 [3.0]                                                                      
      Mediastinum, Inflammation, Chronic                            1 [2.0]                                                         
      Mediastinum, Inflammation, Suppurative                        1 [4.0]                                                         
   Nose                                               (50)         (50)                                                             
      Nasolacrimal Duct, Inflammation                  2 [1.5]      1 [2.0]                                                         
   Pleura                                                          (1)                                                              
      Inflammation, Suppurative                                     1 [4.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (1)          (2)                                                              
      Atrophy                                          1 [4.0]      1 [3.0]                                                         
      Inflammation, Chronic                            1 [4.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (49)         (50)                                                             
      Atrophy                                          1 [3.0]                                                                      
      Cyst                                             3 [2.0]      2 [1.5]                                                         
      Inflammation, Chronic                                         1 [2.0]                                                         
      Metaplasia, Focal, Osseous                       1 [1.0]      8 [1.5]                                                         
      Mineralization, Focal                            1 [3.0]      1 [3.0]                                                         
      Nephropathy                                     18 [1.3]     47 [3.4]                                                         
      Artery, Inflammation, Chronic                    1 [4.0]     16 [2.1]                                                         
      Artery, Mineralization                                        1 [1.0]                                                         
      Glomerulus, Glomerulosclerosis                               40 [2.7]                                                         
      Pelvis, Dilatation                                            1 [3.0]                                                         
      Renal Tubule, Accumulation, Hyaline Droplet      2 [2.5]     14 [2.6]                                                         
      Renal Tubule, Casts Protein                      2 [2.0]                                                                      
      Renal Tubule, Dilatation                         2 [1.0]      2 [1.0]                                                         
      Renal Tubule, Hemorrhage                         1 [2.0]                                                                      
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    8                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE FEMALE                           0            3.0                                                              
                                                      MG/KG/DY     MG/KG/DY                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Renal Tubule, Karyomegaly                                     1 [2.0]                                                         
      Renal Tubule, Necrosis                           1 [2.0]                                                                      
      Renal Tubule, Pigmentation                       2 [2.0]     27 [2.8]                                                         
   Urinary Bladder                                    (50)         (48)                                                             
      Edema                                            1 [3.0]                                                                      
      Artery, Inflammation, Chronic                                 1 [3.0]                                                         
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    9                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                             0            0.1          0.3          1.0          3.0                       
                                                      MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          50           50           50           50           50                        
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 4            6            3            6           13                        
    Natural Death                                      6            3            7            6           17                        
    Accidently Killed                                  1                                                                            
  Survivors                                                                                                                         
    Terminal Sacrifice                                39           41           40           38           18                        
    Natural Death                                                                                          2                        
                                                                                                                                    
  Animals Examined Microscopically                    50           50           50           50           50                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Gallbladder                                        (44)         (43)         (36)         (41)         (38)                      
      Cyst                                             1 [2.0]                                                                      
   Intestine Large, Cecum                             (44)         (47)         (44)         (48)         (39)                      
      Diverticulum                                                  1                                                               
      Edema                                                         1 [3.0]      1 [3.0]                   1 [3.0]                  
      Hemorrhage, Focal                                                                                    1 [2.0]                  
   Intestine Small, Duodenum                          (45)         (48)         (47)         (47)         (40)                      
      Artery, Inflammation, Chronic                                                                        1 [2.0]                  
   Intestine Small, Jejunum                           (45)         (47)         (44)         (47)         (39)                      
      Inflammation, Focal                                                        1 [3.0]                                            
      Peyer's Patch, Hyperplasia, Lymphoid                                       1 [3.0]                                            
   Intestine Small, Ileum                             (44)         (49)         (44)         (47)         (41)                      
      Inflammation                                                  1 [1.0]                                                         
      Peyer's Patch, Hyperplasia, Lymphoid             1 [2.0]      2 [3.0]                                                         
   Liver                                              (50)         (50)         (50)         (50)         (50)                      
      Angiectasis                                                                             6 [2.3]      3 [2.0]                  
      Atrophy, Focal                                   1 [3.0]      1 [1.0]                                                         
      Clear Cell Focus                                 7            5            4            1                                     
      Congestion                                                                 1 [3.0]                                            
      Congestion, Focal                                             3 [2.3]      2 [2.5]      4 [2.5]                               
      Cyst                                             1 [3.0]                                                                      
      Eosinophilic Focus                               6            6            2            1                                     
      Fibrosis, Focal                                  1 [1.0]                                             5 [2.2]                  
      Hematopoietic Cell Proliferation                                                        2 [3.0]                               
      Hemorrhage, Focal                                             2 [2.5]      1 [3.0]      6 [2.3]     21 [2.8]                  
      Infarct                                          1 [4.0]      2 [3.5]      3 [4.0]                                            
      Infiltration Cellular, Mixed Cell               33 [1.4]     25 [1.3]     14 [1.4]     14 [1.6]     32 [2.3]                  
      Inflammation, Chronic                                                                   1 [1.0]                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page   10                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                             0            0.1          0.3          1.0          3.0                       
                                                      MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Inflammation, Chronic, Focal, Suppurative                     1 [3.0]                                                         
      Karyomegaly                                                                1 [1.0]                                            
      Metaplasia, Focal, Lipocyte                                                             1 [2.0]                               
      Mixed Cell Focus                                 3                                                                            
      Thrombosis                                                                              1 [3.0]      5 [2.8]                  
      Bile Duct, Hyperplasia                           2 [2.0]                   1 [1.0]      3 [1.7]      6 [2.3]                  
      Endothelial Cell, Hyperplasia                                                           1 [2.0]      1 [2.0]                  
      Endothelial Cell, Hyperplasia, Focal                                                    2 [1.5]                               
      Hepatocyte, Basophilic Focus                                  1 [1.0]                                                         
      Hepatocyte, Cytomegaly                           4 [1.5]      4 [1.8]     16 [1.7]     33 [1.7]     43 [2.5]                  
      Hepatocyte, Eosinophilic Focus                   2            1            1                                                  
      Hepatocyte, Karyomegaly                          4 [1.5]      4 [1.8]     15 [1.7]     33 [1.8]     43 [2.5]                  
      Hepatocyte, Mixed Cell Focus                                               1 [2.0]                                            
      Hepatocyte, Necrosis, Focal                     18 [1.3]      9 [1.3]      5 [1.8]      6 [2.2]     21 [2.6]                  
      Hepatocyte, Syncytial Alteration, Focal         38 [1.2]     30 [1.2]     31 [1.2]     27 [1.0]                               
      Hepatocyte, Vacuolization Cytoplasmic,                                                                                        
          Diffuse                                      3 [2.7]                                                                      
      Hepatocyte, Vacuolization Cytoplasmic, Focal    18 [1.9]      7 [1.7]      3 [1.7]      5 [1.4]      1 [1.0]                  
      Hepatocyte, Periportal, Vacuolization                                                                                         
          Cytoplasmic                                                            1 [2.0]                   1 [3.0]                  
      Hepatocyte, Centrilobular, Necrosis                           1 [3.0]      3 [3.3]      4 [3.3]     10 [3.0]                  
      Hepatocyte, Centrilobular, Vacuolization                                                                                      
          Cytoplasmic                                                                         1 [2.0]      3 [3.0]                  
      Hepatocyte, Midzonal, Vacuolization                                                                                           
          Cytoplasmic                                  8 [2.0]     14 [2.3]      8 [2.3]      2 [2.5]                               
      Serosa, Fibrosis                                                                                     1 [3.0]                  
      Sinusoid, Dilatation, Diffuse                                                           1 [4.0]                               
   Mesentery                                          (12)         (10)         (9)          (14)         (6)                       
      Angiectasis                                      1 [2.0]      1 [2.0]                                                         
      Inflammation, Chronic                                                      1 [2.0]                                            
      Artery, Inflammation, Chronic, Focal             2 [2.0]      1 [2.0]                   2 [1.5]      1 [2.0]                  
      Fat, Necrosis                                    9 [2.8]      7 [2.4]      8 [2.8]      3 [2.7]      2 [2.5]                  
   Pancreas                                           (49)         (50)         (50)         (50)         (48)                      
      Fibrosis, Focal                                  1 [2.0]                                                                      
      Necrosis, Focal                                  1 [2.0]                                                                      
      Acinus, Atrophy, Focal                                                                               1 [1.0]                  
   Stomach, Forestomach                               (49)         (50)         (50)         (50)         (49)                      
      Diverticulum                                                               1 [2.0]                                            
      Erosion                                          1 [1.0]      1 [1.0]                                                         
      Inflammation, Focal                              2 [1.5]      1 [2.0]      2 [2.5]                                            
      Ulcer                                            1 [2.0]                   1 [3.0]                                            
      Epithelium, Hyperplasia                          2 [2.0]      2 [2.0]      2 [2.5]                                            
   Stomach, Glandular                                 (47)         (48)         (49)         (49)         (46)                      
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page   11                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                             0            0.1          0.3          1.0          3.0                       
                                                      MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Pigmentation, Focal                              1 [1.0]                                1 [2.0]                               
      Glands, Degeneration, Cystic, Focal                                        1 [2.0]      1 [2.0]                               
   Tongue                                                          (1)                                                              
      Epithelium, Hyperplasia, Focal                                1 [3.0]                                                         
   Tooth                                              (24)         (15)         (18)         (4)          (4)                       
      Malformation                                    13 [2.2]      3 [2.3]      8 [2.3]                   2 [2.0]                  
      Peridontal Tissue, Inflammation, Chronic        16 [2.8]     12 [2.7]     12 [2.8]      4 [3.3]      3 [2.3]                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (1)                                                 (1)                       
      Inflammation, Chronic                            1 [3.0]                                                                      
   Heart                                              (50)         (50)         (50)         (50)         (50)                      
      Infiltration Cellular, Mixed Cell                2 [1.5]      3 [1.7]      3 [1.0]      3 [1.0]      3 [1.3]                  
      Inflammation, Chronic, Focal                                               1 [1.0]                                            
      Mineralization, Focal                                                                   1 [2.0]      4 [1.5]                  
      Artery, Inflammation, Chronic                                 2 [2.0]      1 [2.0]      2 [2.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (49)         (49)         (50)         (50)         (49)                      
      Accessory Adrenal Cortical Nodule                             3 [1.0]      1 [1.0]      1 [2.0]      2 [1.0]                  
      Angiectasis                                                   1 [3.0]      1 [2.0]                                            
      Cyst                                                          2 [2.0]      1 [3.0]                                            
      Cytoplasmic Alteration                                                                  2 [3.5]                               
      Cytoplasmic Alteration, Focal                   18 [1.3]      7 [1.3]      8 [1.8]     12 [1.9]     18 [1.4]                  
      Fibrosis                                                                                             1 [2.0]                  
      Hemorrhage                                                                              1 [4.0]                               
      Hyperplasia                                      1 [2.0]                                                                      
      Hyperplasia, Focal                               1 [1.0]                   1 [3.0]                                            
      Hypertrophy                                                                             2 [2.0]                               
      Inflammation, Chronic, Focal                                                                         1 [2.0]                  
      Bilateral, Capsule, Fibrosis                                                            1 [4.0]                               
      Capsule, Fibrosis, Focal                                                   1 [3.0]                                            
      Capsule, Hyperplasia, Focal                      5 [2.0]      7 [2.0]      6 [1.7]      1 [2.0]                               
   Parathyroid Gland                                  (41)         (50)         (44)         (47)         (45)                      
      Angiectasis                                                                             1 [2.0]                               
      Cyst                                             1 [2.0]                                1 [3.0]      2 [3.0]                  
   Pituitary Gland                                    (49)         (47)         (48)         (46)         (47)                      
      Pars Distalis, Cyst                              5 [1.2]      4 [1.8]      2 [1.5]      2 [1.5]      3 [1.3]                  
      Pars Distalis, Cytoplasmic Alteration, Focal     2 [1.0]      2 [1.5]      1 [1.0]      1 [1.0]      1 [2.0]                  
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page   12                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                             0            0.1          0.3          1.0          3.0                       
                                                      MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Pars Distalis, Hyperplasia, Focal                                          2 [1.5]                                            
      Pars Intermedia, Cyst                                                      1 [2.0]                                            
   Thyroid Gland                                      (49)         (50)         (49)         (50)         (50)                      
      Degeneration, Cystic, Focal                      8 [1.4]      8 [1.5]     12 [1.8]      7 [1.7]      7 [1.9]                  
      Follicle, Cyst                                                             1 [2.0]                                            
      Follicular Cell, Hyperplasia                     1 [2.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   Tissue NOS                                                      (2)                       (1)          (1)                       
      Pelvic, Hemorrhage                                            1 [3.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (50)         (50)         (50)         (50)                      
      Inflammation, Chronic                                                                                1 [2.0]                  
   Preputial Gland                                    (50)         (50)         (50)         (50)         (50)                      
      Atrophy                                          1 [3.0]                                                                      
      Degeneration, Cystic                            19 [3.0]     19 [3.0]     16 [3.0]     21 [3.0]     19 [2.9]                  
      Inflammation, Chronic                                         2 [3.5]      1 [3.0]      2 [2.5]      1 [2.0]                  
   Prostate, NOS                                      (50)         (50)         (50)         (50)         (50)                      
      Inflammation, Chronic                                                      2 [1.5]                                            
      Epithelium, Hyperplasia, Focal                   1 [2.0]      1 [2.0]                                                         
   Seminal Vesicle                                    (50)         (50)         (50)         (50)         (50)                      
      Dilatation                                      15 [2.8]     13 [2.5]      8 [2.5]      2 [2.0]      1 [4.0]                  
      Inflammation, Chronic                            2 [2.5]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)         (50)         (50)                      
      Hyperplasia                                      1 [3.0]      2 [2.5]                                1 [3.0]                  
   Lymph Node                                         (2)          (3)          (4)          (7)          (4)                       
      Bronchial, Hyperplasia, Lymphoid                                                                     1 [2.0]                  
      Bronchial, Hyperplasia, Plasma Cell                                        1 [3.0]                                            
      Iliac, Hemorrhage                                                                                    1 [3.0]                  
      Inguinal, Inflammation, Chronic, Focal                                     1 [2.0]                                            
      Mediastinal, Hyperplasia, Lymphoid                                                      1 [3.0]                               
      Mediastinal, Hyperplasia, Plasma Cell                                      1 [3.0]                                            
      Pancreatic, Hyperplasia, Lymphoid                1 [2.0]                                1 [3.0]                               
      Pancreatic, Hyperplasia, Plasma Cell             1 [2.0]                                                                      
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page   13                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                             0            0.1          0.3          1.0          3.0                       
                                                      MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
   Lymph Node, Mandibular                             (49)         (48)         (49)         (49)         (44)                      
      Hemorrhage                                                                 1 [2.0]                                            
      Hyperplasia, Lymphoid                                         1 [3.0]      1 [3.0]                   1 [3.0]                  
      Hyperplasia, Plasma Cell                                      1 [3.0]      1 [3.0]      2 [3.0]                               
   Lymph Node, Mesenteric                             (49)         (48)         (48)         (50)         (50)                      
      Congestion                                                                 1 [4.0]                                            
      Hematopoietic Cell Proliferation                                                                     2 [3.0]                  
      Hemorrhage                                                                 1 [3.0]                   2 [3.0]                  
      Hyperplasia, Lymphoid                            3 [2.3]      2 [3.0]      1 [3.0]      2 [3.0]      4 [2.8]                  
      Hyperplasia, Plasma Cell                         2 [3.0]      3 [3.0]      4 [3.0]      1 [3.0]                               
      Infiltration Cellular, Polymorphonuclear                                   1 [3.0]                                            
      Inflammation, Chronic                                                                                1 [3.0]                  
      Inflammation, Focal, Suppurative                                           1 [3.0]                                            
      Inflammation, Granulomatous                                                                          1 [3.0]                  
   Spleen                                             (49)         (49)         (50)         (50)         (49)                      
      Angiectasis                                                                                          1 [2.0]                  
      Hematopoietic Cell Proliferation                18 [2.3]     16 [2.6]     19 [2.6]     20 [2.7]     33 [2.8]                  
      Hyperplasia, Lymphoid                                         2 [3.0]      3 [3.0]      3 [2.7]                               
      Hyperplasia, Plasma Cell                         1 [2.0]                                                                      
      Necrosis, Focal                                                                                      1 [3.0]                  
      Artery, Inflammation, Chronic, Focal                                                    1 [2.0]                               
   Thymus                                             (42)         (46)         (45)         (43)         (43)                      
      Cyst                                             6 [1.7]      5 [1.8]      4 [2.0]      1 [2.0]      3 [2.0]                  
      Hyperplasia, Lymphoid                                         1 [3.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (50)         (50)         (50)         (50)         (49)                      
      Cyst Epithelial Inclusion                                     1 [2.0]                                                         
      Ulcer                                                                                   1 [2.0]                               
      Subcutaneous Tissue, Edema                                                 2 [2.0]      5 [2.0]     25 [2.0]                  
      Subcutaneous Tissue, Lip, Hyperplasia,                                                                                        
          Lymphoid                                                  1 [3.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)         (50)         (50)         (50)                      
      Cranium, Hyperostosis                            1 [3.0]                                                                      
      Vertebra, Hyperostosis, Focal                   37 [2.9]     36 [2.8]     37 [2.7]     24 [2.8]     27 [2.8]                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page   14                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                             0            0.1          0.3          1.0          3.0                       
                                                      MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)         (50)                      
      Angiectasis, Focal                                                         1 [2.0]                                            
      Atrophy, Focal                                                                                       1 [3.0]                  
      Hemorrhage, Focal                                                                       1 [2.0]                               
      Pigmentation, Focal                                                        1 [2.0]                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)         (50)                      
      Congestion                                                    1 [2.0]      1 [3.0]      2 [3.5]      2 [2.5]                  
      Hemorrhage                                                    1 [2.0]                   8 [2.1]      3 [1.7]                  
      Hyperplasia, Focal, Histiocytic                  1 [3.0]                                1 [2.0]                               
      Hyperplasia, Histiocytic                         1 [2.0]                   4 [3.0]      1 [1.0]                               
      Infiltration Cellular, Mixed Cell                                          1 [2.0]                   4 [2.0]                  
      Metaplasia, Focal, Osseous                                                              1 [1.0]                               
      Pigmentation, Focal                                                                     2 [1.5]                               
      Thrombosis                                                                                           1 [3.0]                  
      Alveolar Epithelium, Hyperplasia                 1 [1.0]      3 [1.7]      3 [2.0]      6 [1.8]      3 [1.3]                  
      Interstitium, Edema                              1 [2.0]                                                                      
      Mediastinum, Inflammation, Chronic               1 [3.0]                                                                      
   Nose                                               (50)         (50)         (50)         (50)         (50)                      
      Inflammation, Suppurative                                     1 [3.0]      1 [3.0]                                            
      Sinus, Foreign Body                                           1 [3.0]      1 [3.0]                                            
      Sinus, Inflammation, Chronic, Suppurative                                  1 [3.0]                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Ear                                                                                                    (1)                       
      Hemorrhage, Focal                                                                                    1 [2.0]                  
   Zymbal's Gland                                     (1)                                                                           
      Cyst, Squamous                                   1 [3.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (49)         (49)         (50)         (50)         (50)                      
      Atrophy, Focal                                                             1 [3.0]                                            
      Congestion                                                                 5 [2.4]      3 [2.3]      1 [2.0]                  
      Cyst                                             8 [1.8]      4 [2.3]      6 [1.8]      7 [1.6]      4 [2.0]                  
      Cyst, Multiple                                                                                       1 [2.0]                  
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page   15                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-06         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                  WITH AVERAGE SEVERITY GRADES[b]                              Date: 09/04/01    
Route: GAVAGE                                                    RIDDELLIINE                                      Time: 09:06:02    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         B6C3F1 MICE MALE                             0            0.1          0.3          1.0          3.0                       
                                                      MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY                  
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URINARY SYSTEM - CONT                                                                                                               
      Hyperplasia, Lymphoid                                                      1 [2.0]                                            
      Infarct                                                       1 [3.0]                                                         
      Inflammation, Chronic, Focal                     1 [2.0]                   1 [3.0]                                            
      Metaplasia, Focal, Osseous                       3 [1.3]      3 [1.3]                  10 [1.4]      4 [1.0]                  
      Nephropathy                                     46 [1.3]     48 [1.5]     48 [1.8]     50 [2.1]     50 [2.8]                  
      Artery, Inflammation, Chronic                                              2 [1.5]                   2 [2.5]                  
      Capsule, Fibrosis                                                                                    1 [3.0]                  
      Glomerulus, Glomerulosclerosis                                1 [1.0]                  42 [1.8]     41 [2.5]                  
      Papilla, Necrosis                                                                       1 [3.0]                               
      Pelvis, Dilatation                                            1 [2.0]      1 [2.0]                   1 [2.0]                  
      Renal Tubule, Accumulation, Hyaline Droplet                   2 [3.0]      1 [3.0]      1 [3.0]      3 [3.0]                  
      Renal Tubule, Dilatation                        16 [1.2]     17 [1.1]     24 [1.3]     29 [1.5]     22 [1.9]                  
      Renal Tubule, Karyomegaly                                                                           12 [1.4]                  
      Renal Tubule, Necrosis, Focal                                                           1 [2.0]                               
      Renal Tubule, Pigmentation                       2 [2.0]                   1 [2.0]                   2 [2.0]                  
      Renal Tubule, Vacuolization Cytoplasmic                       1 [2.0]                                                         
   Urinary Bladder                                    (50)         (50)         (50)         (50)         (50)                      
      Calculus Micro Observation Only                                            1 [3.0]                                            
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
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