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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: PEIRPT18
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 12/08/03
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 14:33:25

                                                          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
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)

                                                              Page   1


NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 12/08/03    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 14:33:25    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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 [1.0]      2 [1.0]      2 [1.0]      2 [1.0]                               
      Inflammation, Chronic Active                     7 [1.0]      9 [1.0]     10 [1.2]      9 [1.1]                               
      Necrosis                                         2 [1.0]      1 [1.0]      1 [1.0]      2 [1.0]                               
      Hepatocyte, Fatty Change                         1 [1.0]                                                                      
      Hepatocyte, Vacuolization Cytoplasmic            7 [1.1]      4 [1.0]      7 [1.1]      8 [1.1]                               
   Stomach, Forestomach                               (9)          (10)         (10)         (10)                                   
      Epithelium, Hyperkeratosis                       1 [1.0]      1 [2.0]      2 [2.0]      1 [1.0]                               
      Epithelium, Hyperplasia                          1 [3.0]      1 [3.0]      3 [2.3]      2 [2.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (9)          (10)         (10)         (10)                                   
      Accessory Adrenal Cortical Nodule                2 [2.0]      2 [2.5]      2 [1.5]      4 [1.3]                               
      Subcapsular, Hyperplasia                         4 [1.0]      7 [1.0]      7 [1.0]      3 [1.0]                               
   Pituitary Gland                                    (9)          (10)         (10)         (10)                                   
      Pars Distalis, Hypertrophy                                                              1 [2.0]                               
      Pars Distalis, Inflammation, Chronic Active      1 [3.0]                                                                      
   Thyroid Gland                                      (9)          (10)         (10)         (10)                                   
      Infiltration Cellular, Lymphocyte                             2 [1.5]      5 [1.2]     10 [1.4]                               
      Follicle, Depletion Secretory                    5 [1.2]      8 [1.5]     10 [2.7]     10 [3.5]                               
      Follicular Cell, Hypertrophy                     1 [1.0]      9 [1.6]      9 [2.9]     10 [3.3]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 12/08/03    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 14:33:25    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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 [2.0]      4 [1.0]      2 [2.0]      5 [2.2]                               
      Inflammation, Chronic Active                     1 [3.0]                                1 [3.0]                               
      Pigmentation, Hemosiderin                                                               1 [3.0]                               
      Corpus Luteum, Degeneration                                                             1 [4.0]                               
      Thecal Cell, Hyperplasia                                                                1 [3.0]                               
   Uterus                                             (9)          (10)         (10)         (10)                                   
      Endometrium, Hyperplasia, Cystic                 8 [1.9]      7 [2.0]      8 [1.5]     10 [1.4]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (9)          (10)         (10)         (10)                                   
      Hyperplasia, Lymphoid                            1 [3.0]      3 [2.7]      2 [2.0]      2 [2.5]                               
   Spleen                                             (9)          (10)         (10)         (10)                                   
      Atrophy                                          1 [3.0]      1 [3.0]                                                         
      Hematopoietic Cell Proliferation                 3 [2.0]      6 [1.8]      8 [1.8]      8 [1.8]                               
   Thymus                                             (8)          (10)         (10)         (10)                                   
      Atrophy                                          1 [4.0]      1 [4.0]      2 [3.0]      1 [3.0]                               
      Cyst                                                          1 [1.0]      2 [1.0]      5 [1.4]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (9)          (10)         (10)         (10)                                   
      Inflammation, Chronic Active                                               1 [2.0]                                            
      Ulcer                                                                      1 [4.0]                                            
      Epidermis, Hyperplasia, Focal                    2 [2.5]      2 [2.0]      6 [3.2]      3 [2.0]                               
      Site of Application - Dermis, Cyst                                                                                            
        Epithelial Inclusion                                                                  1 [3.0]                               
      Site of Application - Epidermis, Hyperplasia                               1 [1.0]                                            
      Subcutaneous Tissue, Cyst Epithelial                                                                                          
        Inclusion                                                                             1 [3.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 12/08/03    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 14:33:25    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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 [2.0]      1 [1.0]                                            
      Metaplasia, Osseous                                                                     1 [1.0]                               
      Perivascular, Infiltration Cellular,                                                                                          
        Lymphocyte                                                                            1 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   Eye                                                (1)                                                                           
      Cornea, Inflammation, Chronic Active             1 [2.0]                                                                      
   Zymbal's Gland                                     (2)                                                                           
      Cyst                                             1 [4.0]                                                                      
      Inflammation, Chronic Active                     1 [4.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (9)          (10)         (10)         (10)                                   
      Mineralization                                                             1 [1.0]                                            
      Nephropathy                                      5 [1.0]      6 [1.0]      8 [1.0]     10 [1.3]                               
      Artery, Inflammation, Chronic Active                          1 [2.0]                                                         
      Cortex, Cyst                                     1 [2.0]                                                                      
      Renal Tubule, Hypertrophy                                                               4 [1.0]                               
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    4                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 12/08/03    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 14:33:25    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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 [1.0]      1 [1.0]      1 [1.0]                               
      Inflammation, Chronic Active                     8 [1.0]      8 [1.0]      6 [1.0]      6 [1.2]                               
      Necrosis                                                                                2 [1.0]                               
      Hepatocyte, Fatty Change                         1 [1.0]                                                                      
      Hepatocyte, Vacuolization Cytoplasmic            5 [1.2]      8 [1.1]      6 [1.0]      2 [1.0]                               
   Mesentery                                          (1)                       (2)                                                 
      Fat, Fibrosis                                    1 [2.0]                   1 [3.0]                                            
      Fat, Inflammation, Chronic Active                1 [2.0]                   2 [2.0]                                            
      Fat, Necrosis                                    1 [4.0]                   2 [4.0]                                            
   Stomach, Forestomach                               (10)         (10)         (10)         (10)                                   
      Epithelium, Hyperkeratosis                                    2 [1.0]                   1 [2.0]                               
      Epithelium, Hyperplasia                                       2 [1.5]                   1 [2.0]                               
   Tooth                                              (2)          (3)          (3)          (2)                                    
      Abscess, Focal                                                                          1                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (10)         (10)         (10)         (10)                                   
      Accessory Adrenal Cortical Nodule                                          2 [1.5]      1 [1.0]                               
      Hypertrophy                                      6 [1.5]      5 [1.2]      6 [1.7]      6 [1.3]                               
   Pituitary Gland                                    (9)          (10)         (10)         (10)                                   
      Pars Distalis, Cyst                              3 [1.0]      3 [1.0]      1 [1.0]      3 [1.0]                               
   Thyroid Gland                                      (10)         (10)         (10)         (10)                                   
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 12/08/03    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 14:33:25    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE                 0 MG/KG      64 MG/KG     128          256                                    
                                                                                MG/KG        MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Infiltration Cellular, Lymphocyte                                          2 [1.0]      1 [1.0]                               
      Follicle, Cyst                                                1 [2.0]                                                         
      Follicle, Depletion Secretory                    8 [1.0]      7 [1.0]      9 [1.3]      9 [1.4]                               
      Follicular Cell, Hypertrophy                                  9 [1.0]      8 [1.5]      8 [1.9]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (10)         (10)         (10)         (10)                                   
      Cyst                                                                       2            2                                     
      Degeneration                                     1 [4.0]      2 [3.0]      3 [4.0]      5 [3.8]                               
      Inflammation, Chronic Active                                               3 [2.0]      2 [1.5]                               
   Testes                                             (10)         (10)         (10)         (10)                                   
      Cyst                                                          1 [2.0]      1 [2.0]      2 [2.5]                               
      Mineralization                                                             1 [1.0]                                            
      Bilateral, Germinal Epithelium, Degeneration                  1 [3.0]      1 [3.0]      2 [3.0]                               
      Germinal Epithelium, Degeneration                1 [3.0]      2 [1.5]      3 [3.0]      6 [2.8]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (10)         (10)         (10)         (10)                                   
      Hyperplasia, Lymphoid                            1 [3.0]                                3 [3.0]                               
   Spleen                                             (10)         (10)         (10)         (10)                                   
      Hematopoietic Cell Proliferation                 3 [2.0]      2 [2.0]      2 [2.5]      3 [1.7]                               
      Hyperplasia, Lymphoid                                                                   1 [2.0]                               
   Thymus                                             (10)         (10)         (10)         (9)                                    
      Atrophy                                          3 [2.0]      2 [2.5]      4 [3.3]      3 [2.3]                               
      Cyst                                             7 [1.0]      1 [2.0]                   3 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (10)         (10)         (10)         (10)                                   
      Hyperkeratosis                                                1 [2.0]                   1 [2.0]                               
      Epidermis, Hyperplasia, Focal                    4 [2.5]      2 [2.0]      1 [2.0]      2 [2.5]                               
      Site of Application - Epidermis, Hyperplasia,                                                                                 
         Focal                                                                   1 [1.0]      1 [1.0]                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-92         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: 26-39 WEEKS                              WITH AVERAGE SEVERITY GRADES[b]                              Date: 12/08/03    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 14:33:25    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         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 [4.0]                                                                      
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (10)         (10)         (10)         (10)                                   
      Inflammation, Chronic Active                                  2 [1.0]      1 [1.0]      1 [2.0]                               
      Alveolar Epithelium, Hyperplasia                              1 [1.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (10)         (10)         (10)         (10)                                   
      Mineralization                                                1 [1.0]                                                         
      Nephropathy                                      7 [1.0]     10 [1.1]      9 [1.1]     10 [1.2]                               
      Cortex, Cyst                                                  3 [1.7]      1 [1.0]                                            
      Glomerulus, Inflammation,                                                                                                     
        Membranoproliferative                                       1 [3.0]      1 [4.0]      1 [1.0]                               
      Papilla, Mineralization                          1 [1.0]                                                                      
      Pelvis, Dilatation                                                                      1 [1.0]                               
      Renal Tubule, Hypertrophy                                                               2 [1.0]                               
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
b  Average severity grade (1-minimal;2-mild;3-moderate;4-marked)                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    7                                                              
                                                                                                                                   
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