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TDMS Study 05161-05 Pathology Tables

NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00
Route: GAVAGE                                                                                                     Time: 12:05:56

                                                          RATS/FINAL#1




       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

                                                              Page   1


NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0            0.01         0.033        0.1          0.33         1.0             
                                                   MG/KG/DY     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           50           
  Early Deaths                                                                                                                      
    Natural Death                                      6           11            6           12            2           31           
    Dosing Accident                                    2            6            3            2            3                        
    Moribund Sacrifice                                 9           11           13           14           16           19           
  Survivors                                                                                                                         
    Terminal Sacrifice                                33           22           28           22           29                        
                                                                                                                                    
  Animals Examined Microscopically                    50           50           50           50           50           50           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (48)         (50)         (48)         (50)         (49)         (50)         
      Inflammation, Chronic                                         2 (4%)                                                          
      Perforation                                                                1 (2%)                                             
   Intestine Large, Colon                             (49)         (50)         (50)         (47)         (50)         (50)         
      Diverticulum                                     1 (2%)                                                                       
   Intestine Large, Cecum                             (50)         (50)         (48)         (47)         (50)         (50)         
      Edema                                                                                                1 (2%)                   
   Liver                                              (50)         (50)         (50)         (50)         (50)         (50)         
      Angiectasis                                      2 (4%)       1 (2%)       2 (4%)                    5 (10%)      1 (2%)      
      Basophilic Focus                                45 (90%)     46 (92%)     44 (88%)     42 (84%)     40 (80%)     20 (40%)     
      Clear Cell Focus                                 9 (18%)      8 (16%)      9 (18%)     13 (26%)     22 (44%)      2 (4%)      
      Cyst                                             1 (2%)                                                                       
      Degeneration, Cystic                                                       1 (2%)                    1 (2%)                   
      Eosinophilic Focus                               1 (2%)       2 (4%)       6 (12%)      4 (8%)      12 (24%)     13 (26%)     
      Hematopoietic Cell Proliferation                 2 (4%)       1 (2%)       4 (8%)                    1 (2%)       3 (6%)      
      Hemorrhage                                                                 2 (4%)                    1 (2%)       7 (14%)     
      Hepatodiaphragmatic Nodule                      13 (26%)      8 (16%)      9 (18%)      6 (12%)      4 (8%)       5 (10%)     
      Infiltration Cellular, Mixed Cell                9 (18%)      7 (14%)      9 (18%)      8 (16%)     15 (30%)      3 (6%)      
      Mixed Cell Focus                                 8 (16%)     10 (20%)     10 (20%)     11 (22%)     23 (46%)      5 (10%)     
      Necrosis, Focal                                  4 (8%)       2 (4%)       3 (6%)       4 (8%)       4 (8%)      15 (30%)     
      Bile Duct, Hyperplasia                           2 (4%)       1 (2%)       4 (8%)       4 (8%)       3 (6%)      10 (20%)     
      Hepatocyte, Cytomegaly                                                     7 (14%)     23 (46%)     32 (64%)     29 (58%)     
      Hepatocyte, Hyperplasia, Atypical                                                                    1 (2%)                   
      Hepatocyte, Hyperplasia, Focal                   1 (2%)                                                                       
      Hepatocyte, Hyperplasia, Regenerative                                                                8 (16%)     50 (100%)    
      Hepatocyte, Vacuolization Cytoplasmic            4 (8%)       5 (10%)      7 (14%)      4 (8%)       3 (6%)       5 (10%)     
      Kupffer Cell, Pigmentation                                    2 (4%)       3 (6%)       2 (4%)       6 (12%)      4 (8%)      
   Mesentery                                          (10)         (10)         (18)         (14)         (13)         (5)          
      Accessory Spleen                                 2 (20%)                   1 (6%)       2 (14%)      1 (8%)                   
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0            0.01         0.033        0.1          0.33         1.0             
                                                   MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Fat, Necrosis                                    8 (80%)     10 (100%)    18 (100%)    12 (86%)      9 (69%)      3 (60%)     
   Pancreas                                           (50)         (50)         (50)         (46)         (50)         (50)         
      Atrophy                                         10 (20%)      3 (6%)       9 (18%)      8 (17%)      4 (8%)       4 (8%)      
      Acinus, Hyperplasia, Focal                       3 (6%)       1 (2%)                                 1 (2%)                   
   Salivary Glands                                    (50)         (50)         (50)         (50)         (50)         (50)         
      Atrophy                                                                                 1 (2%)                    2 (4%)      
   Stomach, Forestomach                               (50)         (50)         (50)         (49)         (49)         (50)         
      Ulcer                                                                      2 (4%)                                             
      Epithelium, Hyperplasia                                       1 (2%)       5 (10%)      1 (2%)       1 (2%)       3 (6%)      
   Stomach, Glandular                                 (50)         (50)         (50)         (49)         (49)         (50)         
      Erosion                                                                                 2 (4%)       1 (2%)       9 (18%)     
      Hemorrhage                                                                                                        1 (2%)      
      Mineralization                                                                                                    1 (2%)      
      Ulcer                                                                                   2 (4%)                    7 (14%)     
   Tooth                                                                                     (1)                                    
      Malformation                                                                            1 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)         (50)         (50)         (50)         (50)         
      Cardiomyopathy                                  12 (24%)     15 (30%)      8 (16%)     13 (26%)      8 (16%)      6 (12%)     
      Thrombosis                                                    1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)         (50)         (50)         (50)         (50)         
      Accessory Adrenal Cortical Nodule                6 (12%)      2 (4%)       6 (12%)      4 (8%)       2 (4%)       7 (14%)     
      Atrophy                                                                                              1 (2%)                   
      Degeneration, Fatty                              9 (18%)      9 (18%)     12 (24%)      8 (16%)     13 (26%)      3 (6%)      
      Hyperplasia, Diffuse                                                       3 (6%)       1 (2%)                                
      Hyperplasia, Focal                               4 (8%)       5 (10%)      6 (12%)      4 (8%)       9 (18%)      3 (6%)      
      Hypertrophy                                                                1 (2%)       1 (2%)                                
      Hypertrophy, Focal                               9 (18%)      5 (10%)      7 (14%)      2 (4%)       4 (8%)       2 (4%)      
      Necrosis                                                                                             1 (2%)                   
   Adrenal Medulla                                    (50)         (49)         (50)         (50)         (50)         (50)         
      Hyperplasia                                      1 (2%)       3 (6%)                    3 (6%)       3 (6%)                   
   Pituitary Gland                                    (50)         (48)         (50)         (49)         (50)         (49)         
      Pars Distalis, Angiectasis                       6 (12%)      6 (13%)      8 (16%)      8 (16%)      9 (18%)      7 (14%)     
      Pars Distalis, Cyst                             16 (32%)     11 (23%)     19 (38%)     16 (33%)     17 (34%)     19 (39%)     
      Pars Distalis, Hyperplasia                       1 (2%)       1 (2%)                                                          
      Pars Distalis, Hyperplasia, Focal               10 (20%)      8 (17%)      9 (18%)     11 (22%)      7 (14%)      6 (12%)     
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0            0.01         0.033        0.1          0.33         1.0             
                                                   MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Pars Intermedia, Angiectasis                     1 (2%)                                 1 (2%)       1 (2%)                   
      Pars Intermedia, Cyst                            1 (2%)                    1 (2%)                                             
   Thyroid Gland                                      (49)         (50)         (49)         (49)         (50)         (50)         
      Ultimobranchial Cyst                             1 (2%)       2 (4%)                                 1 (2%)       2 (4%)      
      C-Cell, Hyperplasia                             22 (45%)      9 (18%)     24 (49%)     15 (31%)     20 (40%)     10 (20%)     
      Follicle, Cyst                                   1 (2%)       1 (2%)       1 (2%)                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Clitoral Gland                                     (49)         (49)         (49)         (48)         (49)         (50)         
      Cyst                                             5 (10%)      2 (4%)       3 (6%)       1 (2%)       4 (8%)       3 (6%)      
      Hyperplasia                                      3 (6%)       5 (10%)      4 (8%)       2 (4%)       2 (4%)                   
      Inflammation, Chronic                            4 (8%)       5 (10%)      4 (8%)       3 (6%)       4 (8%)                   
   Ovary                                              (50)         (49)         (50)         (50)         (50)         (50)         
      Cyst                                            11 (22%)      7 (14%)      8 (16%)      9 (18%)      6 (12%)      9 (18%)     
      Infiltration Cellular, Mixed Cell                1 (2%)                                                                       
   Uterus                                             (50)         (50)         (50)         (50)         (50)         (50)         
      Hydrometra                                       5 (10%)      7 (14%)                   6 (12%)      6 (12%)      6 (12%)     
      Hyperplasia, Cystic                              4 (8%)       3 (6%)       7 (14%)      5 (10%)      2 (4%)       9 (18%)     
      Inflammation, Chronic                                                      2 (4%)                    1 (2%)                   
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)         (50)         (50)         (50)         (50)         
      Hyperplasia                                      6 (12%)      3 (6%)       8 (16%)      7 (14%)     10 (20%)     32 (64%)     
      Inflammation, Granulomatous                                                1 (2%)                                             
      Myelofibrosis                                                 1 (2%)                    1 (2%)       1 (2%)       1 (2%)      
   Lymph Node                                         (26)         (24)         (36)         (19)         (21)         (40)         
      Iliac, Pigmentation                                           1 (4%)                                                          
      Mediastinal, Congestion                          4 (15%)      3 (13%)      3 (8%)       3 (16%)      1 (5%)       9 (23%)     
      Mediastinal, Hemorrhage                          5 (19%)      8 (33%)      9 (25%)      5 (26%)      7 (33%)     25 (63%)     
      Mediastinal, Infiltration Cellular,                                                                                           
          Histiocyte                                   1 (4%)                                                                       
      Mediastinal, Pigmentation                       23 (88%)     22 (92%)     32 (89%)     15 (79%)     16 (76%)     31 (78%)     
      Pancreatic, Hemorrhage                                                                                            2 (5%)      
      Pancreatic, Hyperplasia, Histiocytic                          1 (4%)       1 (3%)                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    4                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0            0.01         0.033        0.1          0.33         1.0             
                                                   MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Pancreatic, Hyperplasia, Lymphoid                1 (4%)       1 (4%)       1 (3%)                    1 (5%)                   
      Pancreatic, Pigmentation                                      1 (4%)       2 (6%)                    4 (19%)      1 (3%)      
      Renal, Pigmentation                                                        2 (6%)                    2 (10%)      1 (3%)      
   Lymph Node, Mandibular                             (50)         (49)         (48)         (50)         (50)         (50)         
      Ectasia                                                                                 3 (6%)                                
      Hemorrhage                                       1 (2%)       1 (2%)       1 (2%)                    1 (2%)                   
      Hyperplasia, Lymphoid                            2 (4%)       3 (6%)       1 (2%)       5 (10%)      5 (10%)                  
      Pigmentation                                     5 (10%)      2 (4%)       2 (4%)      11 (22%)      3 (6%)                   
   Lymph Node, Mesenteric                             (50)         (50)         (50)         (47)         (49)         (49)         
      Congestion                                                                              1 (2%)                    1 (2%)      
      Hemorrhage                                       1 (2%)       2 (4%)       3 (6%)       4 (9%)                    6 (12%)     
      Hyperplasia                                                                                          1 (2%)                   
      Inflammation, Granulomatous                      1 (2%)                                                                       
      Pigmentation                                     3 (6%)       1 (2%)       2 (4%)       2 (4%)       3 (6%)       2 (4%)      
   Spleen                                             (50)         (50)         (50)         (50)         (50)         (50)         
      Congestion                                                                              1 (2%)       3 (6%)       7 (14%)     
      Fibrosis                                         1 (2%)       1 (2%)       2 (4%)                    2 (4%)                   
      Hematopoietic Cell Proliferation                24 (48%)     33 (66%)     25 (50%)     26 (52%)     27 (54%)     34 (68%)     
      Hyperplasia, Stromal                                                                                 1 (2%)                   
      Necrosis                                                                                1 (2%)                                
      Pigmentation                                    37 (74%)     41 (82%)     35 (70%)     34 (68%)     35 (70%)     29 (58%)     
   Thymus                                             (48)         (48)         (46)         (48)         (50)         (49)         
      Cyst                                                                                                 1 (2%)                   
      Hemorrhage                                                    2 (4%)                                              2 (4%)      
      Hyperplasia                                                   1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (50)         (50)         (50)         (50)         (49)         (49)         
      Hyperplasia                                     48 (96%)     46 (92%)     46 (92%)     45 (90%)     44 (90%)     43 (88%)     
   Skin                                               (50)         (50)         (49)         (50)         (50)         (50)         
      Cyst Epithelial Inclusion                                                                            1 (2%)                   
      Hemorrhage                                                    1 (2%)                                                          
      Hyperkeratosis                                                             1 (2%)                                             
      Inflammation, Chronic                                         1 (2%)                                                          
      Ulcer                                                         1 (2%)                                                          
      Epidermis, Hyperplasia                                        1 (2%)                                                          
      Subcutaneous Tissue, Edema                                                              2 (4%)                                
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0            0.01         0.033        0.1          0.33         1.0             
                                                   MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
MUSCULOSKELETAL SYSTEM - CONT                                                                                                       
   Bone                                               (50)         (50)         (50)         (50)         (50)         (50)         
      Cranium, Osteopetrosis                          10 (20%)     10 (20%)     12 (24%)      6 (12%)      7 (14%)                  
      Femur, Osteopetrosis                            12 (24%)      7 (14%)      9 (18%)     15 (30%)     14 (28%)      9 (18%)     
   Skeletal Muscle                                                 (1)          (1)          (2)                       (6)          
      Hemorrhage                                                                                                        4 (67%)     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)         (50)         (50)         (50)         (50)         
      Compression                                      9 (18%)     11 (22%)     15 (30%)      6 (12%)     12 (24%)      2 (4%)      
      Hemorrhage                                       1 (2%)       1 (2%)                    3 (6%)                                
      Hydrocephalus                                    3 (6%)       4 (8%)       8 (16%)      1 (2%)      10 (20%)      3 (6%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)         (50)         (50)         (50)         (50)         
      Congestion                                       4 (8%)       7 (14%)      2 (4%)       8 (16%)      1 (2%)       1 (2%)      
      Edema                                                                                                1 (2%)       2 (4%)      
      Hemorrhage                                       4 (8%)       7 (14%)      1 (2%)       3 (6%)       5 (10%)     19 (38%)     
      Infiltration Cellular, Histiocyte               46 (92%)     41 (82%)     48 (96%)     44 (88%)     49 (98%)     42 (84%)     
      Inflammation, Chronic                                                      1 (2%)                                             
      Inflammation, Granulomatous                      1 (2%)                                                                       
      Metaplasia, Osseous                                           2 (4%)                                                          
      Alveolar Epithelium, Hyperplasia                 5 (10%)      4 (8%)      10 (20%)      5 (10%)      5 (10%)      7 (14%)     
   Nose                                               (50)         (50)         (50)         (49)         (50)         (50)         
      Foreign Body                                     2 (4%)                    1 (2%)       1 (2%)                    1 (2%)      
      Inflammation, Chronic                            3 (6%)                                 2 (4%)                    1 (2%)      
      Olfactory Epithelium, Degeneration                                         1 (2%)       1 (2%)                                
      Respiratory Epithelium, Hyperplasia              1 (2%)                    1 (2%)                                 3 (6%)      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                                                                                 (1)          
      Cataract                                                                                                          1 (100%)    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)         (50)         (50)         (50)         (50)         
      Cyst                                             1 (2%)                                              1 (2%)                   
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS FEMALE                   0            0.01         0.033        0.1          0.33         1.0             
                                                   MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY     MG/KG/DY        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Hydronephrosis                                                             1 (2%)                    1 (2%)                   
      Infarct                                                       1 (2%)                                 1 (2%)                   
      Inflammation, Chronic                                         1 (2%)                                                          
      Nephropathy                                     32 (64%)     32 (64%)     33 (66%)     30 (60%)     38 (76%)     28 (56%)     
      Papilla, Fibrosis, Focal                                                   1 (2%)                                             
      Pelvis, Mineralization                           1 (2%)                                                                       
      Renal Tubule, Cytoplasmic Alteration                          1 (2%)                    1 (2%)                                
      Renal Tubule, Dilatation                                      1 (2%)       2 (4%)                    2 (4%)       1 (2%)      
      Renal Tubule, Hyaline Droplet                   33 (66%)     23 (46%)     30 (60%)     26 (52%)     26 (52%)      9 (18%)     
      Renal Tubule, Mineralization                                                                                      1 (2%)      
      Renal Tubule, Necrosis                                                                  1 (2%)       1 (2%)       6 (12%)     
      Renal Tubule, Pigmentation                      38 (76%)     28 (56%)     31 (62%)     31 (62%)     41 (82%)     23 (46%)     
      Transitional Epithelium, Hyperplasia             1 (2%)       1 (2%)       1 (2%)       1 (2%)                    5 (10%)     
   Urinary Bladder                                    (50)         (50)         (50)         (48)         (50)         (50)         
      Edema                                                         1 (2%)       1 (2%)                                             
      Transitional Epithelium, Hyperplasia                                                                 1 (2%)                   
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    7                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0            1.0                                                                 
                                                   MG/KG/DY     MG/KG/DY                                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          50           50                                                               
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 1            9                                                               
    Natural Death                                                  36                                                               
    Dosing Accident                                                 2                                                               
  Survivors                                                                                                                         
    Terminal Sacrifice                                49            3                                                               
                                                                                                                                    
  Animals Examined Microscopically                    50           50                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (50)                                                             
      Perforation                                                   1 (2%)                                                          
   Intestine Large, Cecum                             (50)         (49)                                                             
      Edema                                            1 (2%)       3 (6%)                                                          
   Intestine Small, Duodenum                          (50)         (50)                                                             
      Hemorrhage                                                    1 (2%)                                                          
      Necrosis                                                      1 (2%)                                                          
   Liver                                              (50)         (50)                                                             
      Basophilic Focus                                32 (64%)     21 (42%)                                                         
      Clear Cell Focus                                 3 (6%)       5 (10%)                                                         
      Degeneration, Cystic                             1 (2%)       3 (6%)                                                          
      Eosinophilic Focus                               3 (6%)      15 (30%)                                                         
      Hematopoietic Cell Proliferation                              2 (4%)                                                          
      Hemorrhage                                                    4 (8%)                                                          
      Hepatodiaphragmatic Nodule                       4 (8%)       4 (8%)                                                          
      Infiltration Cellular, Mixed Cell                8 (16%)                                                                      
      Metaplasia, Osseous                                           1 (2%)                                                          
      Mixed Cell Focus                                 3 (6%)       7 (14%)                                                         
      Necrosis, Focal                                              23 (46%)                                                         
      Bile Duct, Hyperplasia                          48 (96%)     37 (74%)                                                         
      Hepatocyte, Cytomegaly                                       32 (64%)                                                         
      Hepatocyte, Hyperplasia, Atypical                             1 (2%)                                                          
      Hepatocyte, Hyperplasia, Regenerative                        49 (98%)                                                         
      Hepatocyte, Vacuolization Cytoplasmic           30 (60%)      5 (10%)                                                         
      Kupffer Cell, Pigmentation                                    1 (2%)                                                          
   Mesentery                                          (8)          (9)                                                              
      Accessory Spleen                                 1 (13%)      1 (11%)                                                         
      Fat, Necrosis                                    7 (88%)      3 (33%)                                                         
   Pancreas                                           (50)         (50)                                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    8                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0            1.0                                                                 
                                                   MG/KG/DY     MG/KG/DY                                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ALIMENTARY SYSTEM - CONT                                                                                                            
      Atrophy                                          7 (14%)      7 (14%)                                                         
      Acinus, Cytoplasmic Alteration                   1 (2%)                                                                       
      Acinus, Hyperplasia, Focal                                    1 (2%)                                                          
   Salivary Glands                                    (50)         (50)                                                             
      Atrophy                                                       1 (2%)                                                          
      Necrosis                                                      2 (4%)                                                          
   Stomach, Forestomach                               (50)         (50)                                                             
      Edema                                                         2 (4%)                                                          
      Ulcer                                                         3 (6%)                                                          
   Stomach, Glandular                                 (50)         (50)                                                             
      Erosion                                                      10 (20%)                                                         
      Hemorrhage                                                    1 (2%)                                                          
      Ulcer                                                         6 (12%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)                                                             
      Cardiomyopathy                                  32 (64%)     28 (56%)                                                         
      Myocardium, Hemorrhage                                        1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (49)         (50)                                                             
      Accessory Adrenal Cortical Nodule                8 (16%)      1 (2%)                                                          
      Degeneration, Fatty                              5 (10%)      4 (8%)                                                          
      Hyperplasia, Diffuse                                          1 (2%)                                                          
      Hyperplasia, Focal                               3 (6%)       1 (2%)                                                          
      Hypertrophy                                      1 (2%)                                                                       
      Necrosis                                                      1 (2%)                                                          
   Pituitary Gland                                    (50)         (49)                                                             
      Pars Distalis, Cyst                              4 (8%)       2 (4%)                                                          
      Pars Distalis, Hyperplasia, Focal                5 (10%)      4 (8%)                                                          
   Thyroid Gland                                      (50)         (50)                                                             
      Ultimobranchial Cyst                                          1 (2%)                                                          
      C-Cell, Hyperplasia                              4 (8%)       1 (2%)                                                          
      Follicle, Cyst                                   1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    9                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0            1.0                                                                 
                                                   MG/KG/DY     MG/KG/DY                                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (50)                                                             
      Atypia Cellular                                  9 (18%)      9 (18%)                                                         
   Preputial Gland                                    (50)         (50)                                                             
      Inflammation, Chronic                           24 (48%)     16 (32%)                                                         
   Prostate                                           (50)         (50)                                                             
      Inflammation, Chronic                           18 (36%)     15 (30%)                                                         
   Testes                                             (50)         (50)                                                             
      Atrophy                                          3 (6%)       6 (12%)                                                         
      Interstitial Cell, Hyperplasia                  22 (44%)     12 (24%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (49)                                                             
      Hyperplasia                                      1 (2%)      36 (73%)                                                         
      Myelofibrosis                                                 1 (2%)                                                          
   Lymph Node                                         (13)         (39)                                                             
      Bronchial, Hemorrhage                                         1 (3%)                                                          
      Bronchial, Pigmentation                                       1 (3%)                                                          
      Iliac, Necrosis                                               1 (3%)                                                          
      Mediastinal, Congestion                          3 (23%)     11 (28%)                                                         
      Mediastinal, Hemorrhage                          3 (23%)     20 (51%)                                                         
      Mediastinal, Hyperplasia                         1 (8%)                                                                       
      Mediastinal, Necrosis                                         1 (3%)                                                          
      Mediastinal, Pigmentation                       10 (77%)     20 (51%)                                                         
      Pancreatic, Hemorrhage                                        2 (5%)                                                          
      Pancreatic, Pigmentation                                      2 (5%)                                                          
      Renal, Hemorrhage                                             3 (8%)                                                          
      Renal, Necrosis                                               1 (3%)                                                          
      Renal, Pigmentation                                           3 (8%)                                                          
   Lymph Node, Mandibular                             (50)         (50)                                                             
      Congestion                                                    1 (2%)                                                          
      Hemorrhage                                       2 (4%)       1 (2%)                                                          
      Pigmentation                                     1 (2%)       1 (2%)                                                          
   Lymph Node, Mesenteric                             (50)         (50)                                                             
      Congestion                                                    4 (8%)                                                          
      Hemorrhage                                       1 (2%)       8 (16%)                                                         
      Pigmentation                                                  1 (2%)                                                          
   Spleen                                             (50)         (49)                                                             
      Congestion                                                   24 (49%)                                                         
      Fibrosis                                         1 (2%)       1 (2%)                                                          
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page   10                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0            1.0                                                                 
                                                   MG/KG/DY     MG/KG/DY                                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Hematopoietic Cell Proliferation                 1 (2%)      23 (47%)                                                         
      Hyperplasia, Reticulum Cell                                   1 (2%)                                                          
      Necrosis                                                      1 (2%)                                                          
   Thymus                                             (49)         (49)                                                             
      Hemorrhage                                                    4 (8%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (42)         (38)                                                             
      Cyst                                             1 (2%)       1 (3%)                                                          
      Hyperplasia                                      5 (12%)      2 (5%)                                                          
   Skin                                               (50)         (50)                                                             
      Cyst Epithelial Inclusion                        1 (2%)       1 (2%)                                                          
      Hyperkeratosis                                   1 (2%)                                                                       
      Subcutaneous Tissue, Fibrosis                    1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                               (50)         (50)                                                             
      Femur, Osteopetrosis                                          2 (4%)                                                          
   Skeletal Muscle                                    (1)          (5)                                                              
      Hemorrhage                                                    3 (60%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)                                                             
      Compression                                      2 (4%)                                                                       
      Hydrocephalus                                    1 (2%)                                                                       
   Spinal Cord                                                     (5)                                                              
      Hemorrhage                                                    1 (20%)                                                         
      Necrosis                                                      1 (20%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)                                                             
      Edema                                                         5 (10%)                                                         
      Hemorrhage                                       1 (2%)      21 (42%)                                                         
      Infiltration Cellular, Polymorphonuclear                      1 (2%)                                                          
      Infiltration Cellular, Histiocyte               42 (84%)     32 (64%)                                                         
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page   11                                                              
                                                                                                                                   
NTP Experiment-Test: 05161-05         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: CHRONIC                                            RIDDELLIINE                                        Date: 12/15/00    
Route: GAVAGE                                                                                                     Time: 12:05:56    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         FISCHER 344 RATS MALE                     0            1.0                                                                 
                                                   MG/KG/DY     MG/KG/DY                                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
RESPIRATORY SYSTEM - CONT                                                                                                           
      Metaplasia, Osseous                              2 (4%)       1 (2%)                                                          
      Alveolar Epithelium, Hyperplasia                 3 (6%)       1 (2%)                                                          
   Nose                                               (50)         (50)                                                             
      Foreign Body                                     5 (10%)      5 (10%)                                                         
      Hemorrhage                                       1 (2%)       2 (4%)                                                          
      Inflammation, Chronic                            7 (14%)      5 (10%)                                                         
      Respiratory Epithelium, Hyperplasia              7 (14%)      6 (12%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)                                                             
      Glomerulosclerosis                                            1 (2%)                                                          
      Hydronephrosis                                                2 (4%)                                                          
      Infarct                                                       1 (2%)                                                          
      Inflammation, Suppurative                                     1 (2%)                                                          
      Nephropathy                                     47 (94%)     38 (76%)                                                         
      Renal Tubule, Hyaline Droplet                    1 (2%)       3 (6%)                                                          
      Renal Tubule, Necrosis                                        6 (12%)                                                         
      Renal Tubule, Pigmentation                       1 (2%)       4 (8%)                                                          
      Transitional Epithelium, Hyperplasia                          2 (4%)                                                          
   Urinary Bladder                                    (50)         (50)                                                             
      Hemorrhage                                                    1 (2%)                                                          
      Transitional Epithelium, Hyperplasia                          1 (2%)                                                          
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page   12                                                              
                                                                                                                                   
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                             ----------              END OF REPORT             ----------                                           
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