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TDMS Study 97013-92 Pathology Tables

NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: 26-39 WEEKS                         WATER DISINFECTION MODEL (SODIUM BROMATE)                         Date: 12/08/03
Route: SKIN APPLICATION                                                                                           Time: 14:28:00

                                                          FINAL#1 MICE




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  7789-38-0

       Lock Date:  07/30/01

       Cage Range:  All

       Reasons For Removal:    25019 Moribund Sacrifice                25020 Natural Death
                               25021 Terminal Sacrifice

       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: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                         WATER DISINFECTION MODEL (SODIUM BROMATE)                         Date: 12/08/03    
Route: SKIN APPLICATION                                                                                           Time: 14:28:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            0 MG/KG      64 MG/KG     128          256                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          10           10           10           10                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 1            1            2            1                                     
    Natural Death                                      1            2                         1                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                 7            7            8            8                                     
                                                                                                                                    
  Animals Examined Microscopically                     9           10           10           10                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (9)          (10)         (10)         (10)                                   
      Hematopoietic Cell Proliferation                 2 (22%)      2 (20%)      2 (20%)      2 (20%)                               
      Inflammation, Chronic Active                     7 (78%)      9 (90%)     10 (100%)     9 (90%)                               
      Necrosis                                         2 (22%)      1 (10%)      1 (10%)      2 (20%)                               
      Hepatocyte, Fatty Change                         1 (11%)                                                                      
      Hepatocyte, Vacuolization Cytoplasmic            7 (78%)      4 (40%)      7 (70%)      8 (80%)                               
   Stomach, Forestomach                               (9)          (10)         (10)         (10)                                   
      Epithelium, Hyperkeratosis                       1 (11%)      1 (10%)      2 (20%)      1 (10%)                               
      Epithelium, Hyperplasia                          1 (11%)      1 (10%)      3 (30%)      2 (20%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (9)          (10)         (10)         (10)                                   
      Accessory Adrenal Cortical Nodule                2 (22%)      2 (20%)      2 (20%)      4 (40%)                               
      Subcapsular, Hyperplasia                         4 (44%)      7 (70%)      7 (70%)      3 (30%)                               
   Pituitary Gland                                    (9)          (10)         (10)         (10)                                   
      Pars Distalis, Hypertrophy                                                              1 (10%)                               
      Pars Distalis, Inflammation, Chronic Active      1 (11%)                                                                      
   Thyroid Gland                                      (9)          (10)         (10)         (10)                                   
      Infiltration Cellular, Lymphocyte                             2 (20%)      5 (50%)     10 (100%)                              
      Follicle, Depletion Secretory                    5 (56%)      8 (80%)     10 (100%)    10 (100%)                              
      Follicular Cell, Hypertrophy                     1 (11%)      9 (90%)      9 (90%)     10 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                         WATER DISINFECTION MODEL (SODIUM BROMATE)                         Date: 12/08/03    
Route: SKIN APPLICATION                                                                                           Time: 14:28:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            0 MG/KG      64 MG/KG     128          256                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (9)          (10)         (10)         (10)                                   
      Cyst                                             1 (11%)      4 (40%)      2 (20%)      5 (50%)                               
      Inflammation, Chronic Active                     1 (11%)                                1 (10%)                               
      Pigmentation, Hemosiderin                                                               1 (10%)                               
      Corpus Luteum, Degeneration                                                             1 (10%)                               
      Thecal Cell, Hyperplasia                                                                1 (10%)                               
   Uterus                                             (9)          (10)         (10)         (10)                                   
      Endometrium, Hyperplasia, Cystic                 8 (89%)      7 (70%)      8 (80%)     10 (100%)                              
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (9)          (10)         (10)         (10)                                   
      Hyperplasia, Lymphoid                            1 (11%)      3 (30%)      2 (20%)      2 (20%)                               
   Spleen                                             (9)          (10)         (10)         (10)                                   
      Atrophy                                          1 (11%)      1 (10%)                                                         
      Hematopoietic Cell Proliferation                 3 (33%)      6 (60%)      8 (80%)      8 (80%)                               
   Thymus                                             (8)          (10)         (10)         (10)                                   
      Atrophy                                          1 (13%)      1 (10%)      2 (20%)      1 (10%)                               
      Cyst                                                          1 (10%)      2 (20%)      5 (50%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (9)          (10)         (10)         (10)                                   
      Inflammation, Chronic Active                                               1 (10%)                                            
      Ulcer                                                                      1 (10%)                                            
      Epidermis, Hyperplasia, Focal                    2 (22%)      2 (20%)      6 (60%)      3 (30%)                               
      Site of Application - Dermis, Cyst                                                                                            
        Epithelial Inclusion                                                                  1 (10%)                               
      Site of Application - Epidermis, Hyperplasia                               1 (10%)                                            
      Subcutaneous Tissue, Cyst Epithelial                                                                                          
        Inclusion                                                                             1 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                         WATER DISINFECTION MODEL (SODIUM BROMATE)                         Date: 12/08/03    
Route: SKIN APPLICATION                                                                                           Time: 14:28:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            0 MG/KG      64 MG/KG     128          256                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (9)          (10)         (10)         (10)                                   
      Inflammation, Chronic Active                                  1 (10%)      1 (10%)                                            
      Metaplasia, Osseous                                                                     1 (10%)                               
      Perivascular, Infiltration Cellular,                                                                                          
        Lymphocyte                                                                            1 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (1)                                                                           
      Cornea, Inflammation, Chronic Active             1 (100%)                                                                     
   Zymbal's Gland                                     (2)                                                                           
      Cyst                                             1 (50%)                                                                      
      Inflammation, Chronic Active                     1 (50%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (9)          (10)         (10)         (10)                                   
      Mineralization                                                             1 (10%)                                            
      Nephropathy                                      5 (56%)      6 (60%)      8 (80%)     10 (100%)                              
      Artery, Inflammation, Chronic Active                          1 (10%)                                                         
      Cortex, Cyst                                     1 (11%)                                                                      
      Renal Tubule, Hypertrophy                                                               4 (40%)                               
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    4                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                         WATER DISINFECTION MODEL (SODIUM BROMATE)                         Date: 12/08/03    
Route: SKIN APPLICATION                                                                                           Time: 14:28:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              0 MG/KG      64 MG/KG     128          256                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          10           10           10           10                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 1                                      2                                     
    Natural Death                                      1            2            2                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                 8            8            8            8                                     
                                                                                                                                    
  Animals Examined Microscopically                    10           10           10           10                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (10)         (10)         (10)         (10)                                   
      Hematopoietic Cell Proliferation                              1 (10%)      1 (10%)      1 (10%)                               
      Inflammation, Chronic Active                     8 (80%)      8 (80%)      6 (60%)      6 (60%)                               
      Necrosis                                                                                2 (20%)                               
      Hepatocyte, Fatty Change                         1 (10%)                                                                      
      Hepatocyte, Vacuolization Cytoplasmic            5 (50%)      8 (80%)      6 (60%)      2 (20%)                               
   Mesentery                                          (1)                       (2)                                                 
      Fat, Fibrosis                                    1 (100%)                  1 (50%)                                            
      Fat, Inflammation, Chronic Active                1 (100%)                  2 (100%)                                           
      Fat, Necrosis                                    1 (100%)                  2 (100%)                                           
   Stomach, Forestomach                               (10)         (10)         (10)         (10)                                   
      Epithelium, Hyperkeratosis                                    2 (20%)                   1 (10%)                               
      Epithelium, Hyperplasia                                       2 (20%)                   1 (10%)                               
   Tooth                                              (2)          (3)          (3)          (2)                                    
      Abscess, Focal                                                                          1 (50%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (10)         (10)         (10)         (10)                                   
      Accessory Adrenal Cortical Nodule                                          2 (20%)      1 (10%)                               
      Hypertrophy                                      6 (60%)      5 (50%)      6 (60%)      6 (60%)                               
   Pituitary Gland                                    (9)          (10)         (10)         (10)                                   
      Pars Distalis, Cyst                              3 (33%)      3 (30%)      1 (10%)      3 (30%)                               
   Thyroid Gland                                      (10)         (10)         (10)         (10)                                   
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                         WATER DISINFECTION MODEL (SODIUM BROMATE)                         Date: 12/08/03    
Route: SKIN APPLICATION                                                                                           Time: 14:28:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              0 MG/KG      64 MG/KG     128          256                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Infiltration Cellular, Lymphocyte                                          2 (20%)      1 (10%)                               
      Follicle, Cyst                                                1 (10%)                                                         
      Follicle, Depletion Secretory                    8 (80%)      7 (70%)      9 (90%)      9 (90%)                               
      Follicular Cell, Hypertrophy                                  9 (90%)      8 (80%)      8 (80%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (10)         (10)         (10)         (10)                                   
      Cyst                                                                       2 (20%)      2 (20%)                               
      Degeneration                                     1 (10%)      2 (20%)      3 (30%)      5 (50%)                               
      Inflammation, Chronic Active                                               3 (30%)      2 (20%)                               
   Testes                                             (10)         (10)         (10)         (10)                                   
      Cyst                                                          1 (10%)      1 (10%)      2 (20%)                               
      Mineralization                                                             1 (10%)                                            
      Bilateral, Germinal Epithelium, Degeneration                  1 (10%)      1 (10%)      2 (20%)                               
      Germinal Epithelium, Degeneration                1 (10%)      2 (20%)      3 (30%)      6 (60%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (10)         (10)         (10)         (10)                                   
      Hyperplasia, Lymphoid                            1 (10%)                                3 (30%)                               
   Spleen                                             (10)         (10)         (10)         (10)                                   
      Hematopoietic Cell Proliferation                 3 (30%)      2 (20%)      2 (20%)      3 (30%)                               
      Hyperplasia, Lymphoid                                                                   1 (10%)                               
   Thymus                                             (10)         (10)         (10)         (9)                                    
      Atrophy                                          3 (30%)      2 (20%)      4 (40%)      3 (33%)                               
      Cyst                                             7 (70%)      1 (10%)                   3 (33%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (10)         (10)         (10)         (10)                                   
      Hyperkeratosis                                                1 (10%)                   1 (10%)                               
      Epidermis, Hyperplasia, Focal                    4 (40%)      2 (20%)      1 (10%)      2 (20%)                               
      Site of Application - Epidermis, Hyperplasia,                                                                                 
         Focal                                                                   1 (10%)      1 (10%)                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                         WATER DISINFECTION MODEL (SODIUM BROMATE)                         Date: 12/08/03    
Route: SKIN APPLICATION                                                                                           Time: 14:28:00    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              0 MG/KG      64 MG/KG     128          256                                       
                                                                             MG/KG        MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
INTEGUMENTARY SYSTEM - CONT                                                                                                         
      Subcutaneous Tissue, Inflammation, Chronic                                                                                    
        Active                                         1 (10%)                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (10)         (10)         (10)         (10)                                   
      Inflammation, Chronic Active                                  2 (20%)      1 (10%)      1 (10%)                               
      Alveolar Epithelium, Hyperplasia                              1 (10%)                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (10)         (10)         (10)         (10)                                   
      Mineralization                                                1 (10%)                                                         
      Nephropathy                                      7 (70%)     10 (100%)     9 (90%)     10 (100%)                              
      Cortex, Cyst                                                  3 (30%)      1 (10%)                                            
      Glomerulus, Inflammation,                                                                                                     
        Membranoproliferative                                       1 (10%)      1 (10%)      1 (10%)                               
      Papilla, Mineralization                          1 (10%)                                                                      
      Pelvis, Dilatation                                                                      1 (10%)                               
      Renal Tubule, Hypertrophy                                                               2 (20%)                               
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    7                                                              
                                                                                                                                   
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                             ----------              END OF REPORT             ----------                                           
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