National Toxicology Program

National Toxicology Program
https://ntp.niehs.nih.gov/go/15968

TDMS Study 97013-11 Pathology Tables

NTP Experiment-Test: 97013-11         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/04
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 09:21:32

                                                          FINAL#1 MICE




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  7789-38-0

       Lock Date:  07/30/01

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include 001    0 MG/KG
                               Include 002    0 MG/KG
                               Include 003    64 MG/KG
                               Include 004    64 MG/KG
                               Include 005    128     MG/KG
                               Include 006    128     MG/KG
                               Include 007    256     MG/KG
                               Include 008    256     MG/KG


























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: 97013-11         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/04    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 09:21:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE               0 MG/KG      64 MG/KG     128          256                                    
                                                                                MG/KG        MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          15           15           15           15                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 2            4            1            3                                     
    Natural Death                                      2            1            3            1                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                11           10           11           11                                     
                                                                                                                                    
  Animals Examined Microscopically                    15           15           15           15                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Intestine Large, Rectum                            (1)          (2)          (1)                                                 
      Anus, Hyperplasia                                             1 [1.0]                                                         
   Liver                                              (15)         (15)         (15)         (15)                                   
      Hematopoietic Cell Proliferation                 2 [1.0]      2 [1.0]      2 [1.0]      3 [1.0]                               
      Inflammation, Chronic Active                    13 [1.0]     12 [1.0]     12 [1.0]     12 [1.1]                               
      Thrombosis                                                                              1 [3.0]                               
      Hepatocyte, Degeneration                                      1 [2.0]                                                         
      Hepatocyte, Fatty Change                                      1 [1.0]                                                         
      Hepatocyte, Necrosis                             1 [1.0]      2 [1.0]      1 [1.0]      1 [2.0]                               
      Hepatocyte, Vacuolization Cytoplasmic            3 [1.3]      4 [1.3]      3 [1.3]      3 [1.0]                               
   Salivary Glands                                                                           (1)                                    
      Atrophy                                                                                 1 [1.0]                               
      Inflammation, Chronic Active                                                            1 [1.0]                               
   Stomach, Forestomach                               (15)         (15)         (15)         (15)                                   
      Epithelium, Hyperkeratosis                       1 [1.0]      2 [2.0]      1 [2.0]      1 [2.0]                               
      Epithelium, Hyperplasia                          2 [1.0]      2 [2.0]      1 [2.0]      2 [2.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (15)         (15)         (15)         (15)                                   
      Accessory Adrenal Cortical Nodule                3 [1.0]      3 [1.0]      1 [1.0]      1 [1.0]                               
      Subcapsular, Hyperplasia                         4 [1.0]      3 [1.0]      5 [1.0]      3 [1.0]                               
   Pituitary Gland                                    (15)         (15)         (15)         (15)                                   
      Pars Distalis, Cyst                              2 [1.0]      1 [1.0]      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    2                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-11         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/04    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 09:21:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE               0 MG/KG      64 MG/KG     128          256                                    
                                                                                MG/KG        MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
      Pars Intermedia, Cyst                            1 [1.0]                                                                      
   Thyroid Gland                                      (15)         (15)         (15)         (15)                                   
      Ectopic Thymus                                   1 [1.0]                                                                      
      Infiltration Cellular, Lymphocyte                             6 [1.0]      3 [1.0]     12 [1.3]                               
      Follicle, Cyst                                   1 [1.0]                                1 [2.0]                               
      Follicle, Depletion Secretory                    6 [1.2]     11 [1.2]     13 [1.5]     14 [2.6]                               
      Follicular Cell, Hypertrophy                     1 [1.0]      9 [1.0]     12 [1.9]     13 [2.8]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (15)         (15)         (15)         (15)                                   
      Atrophy                                                                    1 [3.0]                                            
      Cyst                                                                       1 [2.0]      3 [1.0]                               
      Hemorrhage                                                                 1 [2.0]                                            
      Pigmentation                                                               1 [3.0]                                            
   Uterus                                             (15)         (15)         (15)         (15)                                   
      Endometrium, Hyperplasia, Cystic                11 [1.0]      9 [1.3]     10 [1.3]     10 [1.2]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node                                                      (2)                       (2)                                    
      Mediastinal, Hyperplasia, Lymphoid                            1 [2.0]                                                         
   Lymph Node, Mandibular                             (15)         (14)         (14)         (15)                                   
      Hyperplasia, Lymphoid                            4 [2.3]      2 [3.5]      2 [2.0]      3 [3.0]                               
   Lymph Node, Mesenteric                             (14)         (14)         (13)         (15)                                   
      Hyperplasia, Lymphoid                                                                   1 [3.0]                               
   Spleen                                             (15)         (15)         (15)         (15)                                   
      Atrophy                                                       1 [2.0]      1 [3.0]      1 [2.0]                               
      Hematopoietic Cell Proliferation                 3 [1.7]      5 [1.4]      9 [1.9]     10 [2.1]                               
   Thymus                                             (15)         (14)         (15)         (15)                                   
      Atrophy                                          1 [3.0]      3 [3.0]      4 [2.8]      2 [2.5]                               
      Cyst                                             2 [1.0]      4 [1.0]      2 [1.0]      3 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY 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: 97013-11         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/04    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 09:21:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE               0 MG/KG      64 MG/KG     128          256                                    
                                                                                MG/KG        MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
INTEGUMENTARY SYSTEM - CONT                                                                                                         
   Skin                                               (15)         (15)         (15)         (15)                                   
      Hyperkeratosis                                                1 [4.0]                                                         
      Inflammation, Chronic Active                                  1 [4.0]      1 [2.0]      1 [4.0]                               
      Inflammation, Suppurative                                     1 [3.0]                                                         
      Ulcer                                                                                   1 [4.0]                               
      Epidermis, Hyperplasia, Focal                    2 [2.0]      3 [2.3]      3 [3.3]      1 [3.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   Bone                                                            (1)                                                              
      Fracture                                                      1                                                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (15)         (15)         (15)                                   
      Inflammation, Chronic Active                                  2 [1.0]                                                         
      Thrombosis                                                                              1 [1.0]                               
      Alveolar Epithelium, Hyperplasia                                                        1 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)         (15)         (15)         (15)                                   
      Nephropathy                                      8 [1.0]      7 [1.0]     13 [1.0]     15 [1.0]                               
      Renal Tubule, Dilatation                         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    4                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-11         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/04    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 09:21:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE                 0 MG/KG      64 MG/KG     128          256                                    
                                                                                MG/KG        MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          15           15           15           15                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 2            1                                                               
    Natural Death                                      1            3            2                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                12           11           13           15                                     
                                                                                                                                    
  Animals Examined Microscopically                    15           15           15           15                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (15)         (15)         (15)         (15)                                   
      Hematopoietic Cell Proliferation                                           1 [1.0]      1 [1.0]                               
      Inflammation, Chronic Active                    10 [1.0]      6 [1.0]      9 [1.0]     11 [1.0]                               
      Hepatocyte, Necrosis                             1 [2.0]      2 [2.0]                                                         
      Hepatocyte, Vacuolization Cytoplasmic            6 [1.2]      4 [1.3]      3 [1.0]      6 [1.8]                               
   Mesentery                                                       (1)          (1)                                                 
      Fat, Necrosis                                                 1 [4.0]      1 [4.0]                                            
   Stomach, Forestomach                               (15)         (15)         (15)         (15)                                   
      Epithelium, Hyperplasia                          1 [2.0]      2 [1.5]      1 [3.0]                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (15)         (15)         (15)         (15)                                   
      Accessory Adrenal Cortical Nodule                1 [1.0]                                                                      
      Hypertrophy                                      8 [1.5]      4 [1.5]      1 [1.0]      3 [1.3]                               
      Subcapsular, Hyperplasia                                                   1 [1.0]                                            
   Pituitary Gland                                    (15)         (14)         (15)         (15)                                   
      Pars Distalis, Cyst                                           3 [1.0]      4 [1.0]      3 [1.0]                               
      Pars Distalis, Hyperplasia                                                 1 [1.0]                                            
   Thyroid Gland                                      (15)         (15)         (15)         (15)                                   
      Infiltration Cellular, Lymphocyte                                          1 [1.0]                                            
      Follicle, Depletion Secretory                    7 [1.0]      4 [1.0]      5 [1.0]     11 [1.1]                               
      Follicular Cell, Hypertrophy                                  7 [1.0]     10 [1.3]     14 [1.4]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
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: 97013-11         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/04    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 09:21:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE                 0 MG/KG      64 MG/KG     128          256                                    
                                                                                MG/KG        MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (15)         (15)         (15)         (15)                                   
      Degeneration                                     1 [4.0]                                2 [4.0]                               
   Testes                                             (15)         (15)         (15)         (15)                                   
      Cyst                                             1 [3.0]                                1 [2.0]                               
      Germinal Epithelium, Degeneration                2 [2.0]                   2 [2.0]      3 [1.7]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (15)         (15)         (15)         (15)                                   
      Necrosis, Lymphoid                               1 [2.0]      1 [1.0]                                                         
   Lymph Node, Mesenteric                             (15)         (15)         (15)         (15)                                   
      Necrosis, Lymphoid                               1 [2.0]                                                                      
   Spleen                                             (15)         (15)         (15)         (15)                                   
      Atrophy                                          1 [3.0]                                                                      
      Hematopoietic Cell Proliferation                                           1 [2.0]      2 [2.0]                               
   Thymus                                             (14)         (15)         (15)         (15)                                   
      Atrophy                                          1 [2.0]      4 [2.5]      1 [3.0]      4 [2.5]                               
      Cyst                                             2 [1.0]      2 [1.5]      2 [1.0]      5 [1.0]                               
      Ectopic Parathyroid Gland                                     1 [1.0]                                                         
      Ectopic Thyroid                                               1 [2.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (15)         (15)         (15)         (15)                                   
      Hyperkeratosis                                   2 [2.0]                   3 [1.7]      4 [2.0]                               
      Hyperkeratosis, Focal                            1 [2.0]                                                                      
      Inflammation, Chronic Active                                  1 [1.0]                                                         
      Epidermis, Hyperplasia, Focal                    3 [2.0]      2 [1.5]      3 [1.3]      4 [1.8]                               
      Site of Application - Epidermis, Hyperplasia,                                                                                 
         Focal                                                                                1 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 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    6                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-11         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/18/04    
Route: SKIN APPLICATION                           WATER DISINFECTION MODEL (SODIUM BROMATE)                       Time: 09:21:32    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE                 0 MG/KG      64 MG/KG     128          256                                    
                                                                                MG/KG        MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (15)         (15)         (15)                                   
      Inflammation, Chronic Active                                  1 [1.0]                                                         
      Pigmentation                                                  1 [1.0]                                                         
      Thrombosis                                                                              1 [3.0]                               
      Alveolar Epithelium, Hyperplasia                 1 [1.0]                                                                      
      Alveolus, Infiltration Cellular, Histiocyte                   1 [1.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)         (15)         (15)         (15)                                   
      Nephropathy                                      8 [1.0]      8 [1.1]     14 [1.0]     14 [1.1]                               
      Artery, Inflammation, Chronic Active             1 [2.0]                                                                      
      Renal Tubule, Dilatation                         1 [2.0]                                2 [1.5]                               
   Urethra                                                                                   (1)                                    
      Bulbourethral Gland, Cyst                                                               1 [4.0]                               
                                                                                                                                    
                                                                                                                                    
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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                             ----------              END OF REPORT             ----------                                           
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NTP is located at the National Institute of Environmental Health Sciences, part of the National Institutes of Health.