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TDMS Study 05121-99 Pathology Tables


                                     INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)
                                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE


NTP Experiment-Test: 05121-99                                                                                     Report: PEIRPT03
Study Type: CHRONIC                                                                                               Date: 03/15/95
Route: GAVAGE                                                                                                     Time: 17:07:00


                                                 05121/07 - 05121/08 COMPARISON


       Facility:  BATTELLE COLUMBUS LABORATORY

       Chemical CAS #:  6533-68-2

       Lock Date:  06/01/92

       Cage Range:  All

       Reasons For Removal:    25022 Accidently Killed                 25018 Dosing Accident
                               25019 Moribund Sacrifice                25020 Natural Death
                               25021 Terminal Sacrifice

       Removal Date Range:     All

       Treatment Groups:       Include 001    0 MG/KG
                               Include 002    0 MG/KG
                               Include 003    RTD     0 MG/KG
                               Include 005    RTD     0 MG/KG


























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

                                                             Page   1

NTP Experiment-Test: 05121-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                            Date: 03/15/95  
Route: GAVAGE                                                                                                     Time: 17:07:00  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          70           60                                                               
  Early Deaths                                                                                                                      
    Natural Death                                      7            1                                                               
    Moribund Sacrifice                                 9            2                                                               
    Dosing Accident                                    2                                                                            
  Survivors                                                                                                                         
    Terminal Sacrifice                                33           47                                                               

  Animals Examined Microscopically                    51           50                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (51)         (50)                                                             
      Perforation                                      1 (2%)                                                                       
      Periesophageal Tissue, Inflammation,                                                                                          
          Suppurative                                  3 (6%)                                                                       
   Intestine Small, Jejunum                           (51)         (50)                                                             
      Hyperplasia, Lymphoid                            2 (4%)                                                                       
   Liver                                              (51)         (50)                                                             
      Angiectasis                                      1 (2%)       1 (2%)                                                          
      Basophilic Focus                                 1 (2%)       1 (2%)                                                          
      Eosinophilic Focus                              17 (33%)                                                                      
      Hyperplasia, Lymphoid                                         1 (2%)                                                          
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Mixed Cell Focus                                 6 (12%)      2 (4%)                                                          
      Centrilobular, Necrosis                                       1 (2%)                                                          
      Serosa, Pigmentation, Hemosiderin                             1 (2%)                                                          
   Mesentery                                          (7)          (2)                                                              
      Fat, Necrosis                                    6 (86%)                                                                      
   Pancreas                                           (51)         (50)                                                             
      Atrophy                                          5 (10%)                                                                      
      Hypertrophy                                      1 (2%)                                                                       
      Acinus, Hyperplasia, Focal                                    3 (6%)                                                          
      Duct, Cyst                                       2 (4%)                                                                       
   Salivary Glands                                    (51)         (50)                                                             
      Duct, Hyperplasia                                1 (2%)                                                                       
   Stomach, Forestomach                               (51)         (50)                                                             
      Erosion                                                       1 (2%)                                                          
      Hyperplasia, Focal                               6 (12%)     29 (58%)                                                         
      Infiltration Cellular, Mast Cell                              1 (2%)                                                          
   Stomach, Glandular                                 (51)         (50)                                                             
      Erosion                                          2 (4%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    2                                                              
NTP Experiment-Test: 05121-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                            Date: 03/15/95  
Route: GAVAGE                                                                                                     Time: 17:07:00  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Blood Vessel                                       (51)         (50)                                                             
      Aorta, Inflammation, Chronic Active              1 (2%)                                                                       
   Heart                                              (51)         (50)                                                             
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Mineralization                                   2 (4%)       2 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (51)         (49)                                                             
      Hyperplasia                                      1 (2%)       2 (4%)                                                          
      Hypertrophy                                                   1 (2%)                                                          
   Adrenal Medulla                                    (51)         (49)                                                             
      Hyperplasia                                      3 (6%)                                                                       
   Islets, Pancreatic                                 (51)         (50)                                                             
      Hyperplasia                                      1 (2%)                                                                       
   Pituitary Gland                                    (50)         (46)                                                             
      Pars Distalis, Hyperplasia                      24 (48%)      1 (2%)                                                          
      Pars Intermedia, Hyperplasia                                  1 (2%)                                                          
   Thyroid Gland                                      (51)         (50)                                                             
      Inflammation, Chronic Active                     1 (2%)       1 (2%)                                                          
      Follicular Cell, Hyperplasia                    16 (31%)      2 (4%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (51)         (50)                                                             
      Atrophy                                                       1 (2%)                                                          
      Cyst                                            16 (31%)     13 (26%)                                                         
      Hemorrhage                                                    1 (2%)                                                          
   Uterus                                             (51)         (50)                                                             
      Hyperplasia, Cystic                             38 (75%)     16 (32%)                                                         
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Inflammation, Suppurative                                     1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    3                                                              
NTP Experiment-Test: 05121-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                            Date: 03/15/95  
Route: GAVAGE                                                                                                     Time: 17:07:00  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (51)         (50)                                                             
      Myelofibrosis                                   22 (43%)      7 (14%)                                                         
      Erythroid Cell, Hyperplasia                      3 (6%)                                                                       
      Myeloid Cell, Hyperplasia                        9 (18%)      1 (2%)                                                          
   Lymph Node, Mandibular                             (50)         (50)                                                             
      Hyperplasia, Lymphoid                            1 (2%)       1 (2%)                                                          
   Spleen                                             (51)         (50)                                                             
      Depletion Lymphoid                               2 (4%)                                                                       
      Hematopoietic Cell Proliferation                17 (33%)      3 (6%)                                                          
      Hyperplasia, Lymphoid                            3 (6%)       1 (2%)                                                          
      Hyperplasia, Plasma Cell                         1 (2%)                                                                       
   Thymus                                             (48)         (45)                                                             
      Atrophy                                          3 (6%)       1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                      (51)         (50)                                                             
      Hyperplasia                                      1 (2%)                                                                       
   Skin                                               (51)         (50)                                                             
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Ulcer                                            1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (51)         (50)                                                             
      Infarct                                          1 (2%)                                                                       
      Neuron, Necrosis                                 1 (2%)                                                                       
   Peripheral Nerve                                   (2)                                                                           
      Degeneration                                     2 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (51)         (50)                                                             
      Infiltration Cellular, Histiocyte                             2 (4%)                                                          
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Alveolar Epithelium, Hyperplasia                              1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    4                                                              
NTP Experiment-Test: 05121-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                            Date: 03/15/95  
Route: GAVAGE                                                                                                     Time: 17:07:00  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE FEMALE                        0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (2)                                                                           
      Cornea, Inflammation, Chronic Active             2 (100%)                                                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (51)         (50)                                                             
      Cyst                                             1 (2%)                                                                       
      Infarct                                          1 (2%)                                                                       
      Nephropathy                                     23 (45%)     16 (32%)                                                         
      Renal Tubule, Necrosis                                        1 (2%)                                                          
      Renal Tubule, Necrosis, Acute                    1 (2%)                                                                       
                                                                                                                                    

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

                                                             Page    5                                                              
NTP Experiment-Test: 05121-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                            Date: 03/15/95  
Route: GAVAGE                                                                                                     Time: 17:07:00  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________

DISPOSITION SUMMARY                                                                                                                 

  Animals Initially In Study                          70           60                                                               
  Early Deaths                                                                                                                      
    Natural Death                                      5            1                                                               
    Moribund Sacrifice                                 4                                                                            
  Survivors                                                                                                                         
    Natural Death                                      1                                                                            
    Terminal Sacrifice                                40           49                                                               

  Animals Examined Microscopically                    50           50                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (50)         (50)                                                             
      Cyst                                             1 (2%)                                                                       
      Periesophageal Tissue, Inflammation,                                                                                          
          Suppurative                                  1 (2%)       1 (2%)                                                          
   Intestine Small, Jejunum                           (50)         (50)                                                             
      Hyperplasia, Lymphoid                                         1 (2%)                                                          
   Liver                                              (50)         (50)                                                             
      Basophilic Focus                                 3 (6%)                                                                       
      Clear Cell Focus                                12 (24%)      1 (2%)                                                          
      Eosinophilic Focus                              21 (42%)      1 (2%)                                                          
      Fatty Change                                     1 (2%)                                                                       
      Hematopoietic Cell Proliferation                 2 (4%)                                                                       
      Inflammation, Chronic Active                     1 (2%)                                                                       
      Mixed Cell Focus                                 5 (10%)                                                                      
      Necrosis                                         1 (2%)       1 (2%)                                                          
      Bile Duct, Hyperplasia, Cystic                                1 (2%)                                                          
   Mesentery                                          (4)          (1)                                                              
      Fibrosis                                                      1 (100%)                                                        
      Fat, Necrosis                                    2 (50%)                                                                      
   Pancreas                                           (50)         (50)                                                             
      Atrophy                                          2 (4%)                                                                       
   Stomach, Forestomach                               (50)         (50)                                                             
      Hyperplasia, Focal                               3 (6%)      38 (76%)                                                         
   Stomach, Glandular                                 (50)         (50)                                                             
      Dysplasia                                                     1 (2%)                                                          
   Tongue                                                          (1)                                                              
      Mineralization                                                1 (100%)                                                        
   Tooth                                              (14)         (2)                                                              
      Dysplasia                                       13 (93%)      2 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    6                                                              
NTP Experiment-Test: 05121-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                            Date: 03/15/95  
Route: GAVAGE                                                                                                     Time: 17:07:00  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   Heart                                              (50)         (50)                                                             
      Mineralization                                   2 (4%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (50)         (50)                                                             
      Accessory Adrenal Cortical Nodule                1 (2%)       2 (4%)                                                          
      Hyperplasia                                     23 (46%)     14 (28%)                                                         
      Capsule, Hyperplasia, Adenomatous                7 (14%)      6 (12%)                                                         
   Adrenal Medulla                                    (49)         (50)                                                             
      Inflammation, Chronic Active                     1 (2%)                                                                       
   Islets, Pancreatic                                 (50)         (50)                                                             
      Hyperplasia                                     29 (58%)      1 (2%)                                                          
   Pituitary Gland                                    (48)         (48)                                                             
      Pars Distalis, Hyperplasia                       1 (2%)                                                                       
   Thyroid Gland                                      (50)         (50)                                                             
      Follicular Cell, Hyperplasia                    13 (26%)      1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (50)         (50)                                                             
      Granuloma Sperm                                  1 (2%)                                                                       
   Preputial Gland                                    (50)         (50)                                                             
      Inflammation, Chronic Active                     1 (2%)       2 (4%)                                                          
      Duct, Ectasia                                   47 (94%)     24 (48%)                                                         
   Seminal Vesicle                                    (50)         (50)                                                             
      Inflammation, Chronic Active                     1 (2%)                                                                       
   Testes                                             (50)         (50)                                                             
      Atrophy                                          2 (4%)       1 (2%)                                                          
      Hypoplasia                                                    1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Bone Marrow                                        (50)         (50)                                                             
      Myeloid Cell, Hyperplasia                        1 (2%)                                                                       
   Lymph Node                                         (2)                                                                           
      Mediastinal, Hyperplasia, Lymphoid               1 (50%)                                                                      
   Lymph Node, Mesenteric                             (48)         (50)                                                             

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

                                                             Page    7                                                              
NTP Experiment-Test: 05121-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                            Date: 03/15/95  
Route: GAVAGE                                                                                                     Time: 17:07:00  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
      Hematopoietic Cell Proliferation                 2 (4%)                                                                       
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
   Spleen                                             (50)         (50)                                                             
      Angiectasis                                      1 (2%)                                                                       
      Hematopoietic Cell Proliferation                 8 (16%)      2 (4%)                                                          
      Hyperplasia, Lymphoid                            1 (2%)                                                                       
   Thymus                                             (42)         (45)                                                             
      Atrophy                                          6 (14%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (50)         (50)                                                             
      Subcutaneous Tissue, Lymphangiectasis            1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Brain                                              (50)         (50)                                                             
      Neuron, Necrosis                                 1 (2%)                                                                       
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (50)         (50)                                                             
      Bronchiectasis, Focal                                         1 (2%)                                                          
      Embolus                                          1 (2%)                                                                       
      Inflammation, Suppurative                        1 (2%)                                                                       
      Alveolar Epithelium, Hyperplasia                 8 (16%)      5 (10%)                                                         
   Nose                                               (50)         (50)                                                             
      Respiratory Epithelium, Inflammation,                                                                                         
          Chronic Active                                            1 (2%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Harderian Gland                                    (16)         (22)                                                             
      Hyperplasia                                      1 (6%)       1 (5%)                                                          
____________________________________________________________________________________________________________________________________
                                                                                                                                    

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

                                                             Page    8                                                              
NTP Experiment-Test: 05121-99         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: CHRONIC                                SCOPOLAMINE HYDROBROMIDE TRIHYDRATE                            Date: 03/15/95  
Route: GAVAGE                                                                                                     Time: 17:07:00  
____________________________________________________________________________________________________________________________________

         B6C3F1 MICE MALE                          0 MG/KG      RTD                                                                 
                                                                0 MG/KG                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (50)         (50)                                                             
      Cyst                                             6 (12%)                                                                      
      Inflammation, Chronic Active                     2 (4%)                                                                       
      Nephropathy                                     48 (96%)     47 (94%)                                                         
      Renal Tubule, Hyperplasia                                     1 (2%)                                                          
   Urinary Bladder                                    (50)         (50)                                                             
      Inflammation, Chronic Active                     2 (4%)                                                                       
                                                                                                                                    

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

                                                             Page    9                                                              
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