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TDMS Study 97013-08 Pathology Tables

NTP Experiment-Test: 97013-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/11/04
Route: GAVAGE                                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                    Time: 08:49:14

                                                          FINAL#1 MICE




       Facility:  Battelle Columbus Laboratory

       Chemical CAS #:  75-27-4

       Lock Date:  07/19/01

       Cage Range:  All

       Reasons For Removal:    All

       Removal Date Range:     All

       Treatment Groups:       Include 002    0 MG/KG
                               Include 004    25 MG/KG
                               Include 006    50 MG/KG
                               Include 008    100     MG/KG
                               Include 001    0 MG/KG
                               Include 003    25 MG/KG
                               Include 005    50 MG/KG
                               Include 007    100     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: 97013-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/11/04    
Route: GAVAGE                                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                    Time: 08:49:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE               0 MG/KG      25 MG/KG     50 MG/KG     100                                    
                                                                                             MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          15           15           15           15                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 1                                      1                                     
    Dosing Accident                                    1                                      1                                     
    Natural Death                                      2            1            2                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                11           14           13           13                                     
                                                                                                                                    
  Animals Examined Microscopically                    15           15           15           15                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (1)                                    (1)                                    
      Perforation                                      1                                      1                                     
   Liver                                              (15)         (15)         (15)         (15)                                   
      Basophilic Focus                                 1                                                                            
      Cyst                                                                       1 [2.0]                                            
      Hematopoietic Cell Proliferation                 1 [1.0]                   1 [1.0]      1 [1.0]                               
      Hemorrhage                                                    1 [2.0]                                                         
      Hepatodiaphragmatic Nodule                                    1                                                               
      Inflammation                                    11 [1.0]     13 [1.0]     13 [1.1]     13 [1.1]                               
      Necrosis                                         1 [1.0]                   4 [1.0]      1 [1.0]                               
      Hepatocyte, Fatty Change                                      5 [1.0]      8 [1.0]      7 [1.1]                               
      Hepatocyte, Vacuolization Cytoplasmic                         6 [1.0]      4 [1.3]      3 [1.0]                               
   Salivary Glands                                    (1)                                    (1)                                    
      Atrophy                                                                                 1 [2.0]                               
   Stomach, Forestomach                               (15)         (15)         (15)         (15)                                   
      Hyperkeratosis                                   1 [1.0]                                                                      
      Epithelium, Hyperplasia                                       1 [1.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (15)         (15)         (15)         (15)                                   
      Mineralization                                                1 [1.0]                                                         
      Subcapsular, Hyperplasia                         7 [1.0]     10 [1.0]      8 [1.0]      6 [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: 97013-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/11/04    
Route: GAVAGE                                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                    Time: 08:49:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE               0 MG/KG      25 MG/KG     50 MG/KG     100                                    
                                                                                             MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
   Parathyroid Gland                                               (1)                                                              
      Cyst                                                          1 [1.0]                                                         
   Pituitary Gland                                    (15)         (15)         (15)         (15)                                   
      Angiectasis                                                                1 [2.0]                                            
      Cyst                                             1 [1.0]                   1 [1.0]      2 [1.0]                               
   Thyroid Gland                                      (15)         (15)         (15)         (15)                                   
      Cyst                                             2 [1.0]      2 [1.0]      3 [1.3]      1 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (15)         (15)         (15)         (15)                                   
      Atrophy                                                                                 1 [2.0]                               
      Cyst                                             4 [1.3]      2 [1.0]      4 [1.5]      4 [1.3]                               
   Uterus                                             (15)         (15)         (15)         (15)                                   
      Atrophy                                                                                 1 [2.0]                               
      Inflammation                                                  1 [1.0]                                                         
      Endometrium, Hyperplasia, Cystic                12 [1.0]      9 [1.0]     12 [1.0]     13 [1.1]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (14)         (15)         (15)         (15)                                   
      Hyperplasia                                                                             1 [2.0]                               
      Infiltration Cellular, Plasma Cell               1 [2.0]                                1 [1.0]                               
   Lymph Node, Mesenteric                             (14)         (15)         (15)         (15)                                   
      Atrophy                                                       1 [3.0]                                                         
   Spleen                                             (15)         (15)         (15)         (15)                                   
      Hematopoietic Cell Proliferation                                           2 [1.0]      1 [1.0]                               
      Lymphoid Follicle, Atrophy                       3 [1.7]                                1 [2.0]                               
   Thymus                                             (13)         (15)         (15)         (15)                                   
      Atrophy                                          2 [3.0]      3 [2.0]      1 [2.0]      3 [2.7]                               
      Cyst                                             2 [1.0]      5 [1.0]      5 [1.0]      2 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   None                                                                                                                             
                                                                                                                                    
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: 97013-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/11/04    
Route: GAVAGE                                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                    Time: 08:49:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE               0 MG/KG      25 MG/KG     50 MG/KG     100                                    
                                                                                             MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (15)         (15)         (15)                                   
      Inflammation                                                               2 [1.0]                                            
      Thrombosis                                                                              1 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)         (15)         (15)         (15)                                   
      Casts Protein                                    4 [1.0]      5 [1.0]      5 [1.0]      4 [1.0]                               
      Cyst                                                                       1 [1.0]      2 [1.0]                               
      Mineralization                                                                          1 [1.0]                               
      Nephropathy                                      1 [1.0]      3 [1.0]      3 [1.0]      1 [1.0]                               
      Renal Tubule, Degeneration                                                 1 [1.0]                                            
      Renal Tubule, Dilatation                         1 [1.0]                                                                      
      Renal Tubule, Hypertrophy                        1 [1.0]      1 [1.0]      1 [1.0]      8 [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: 97013-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/11/04    
Route: GAVAGE                                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                    Time: 08:49:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE                 0 MG/KG      25 MG/KG     50 MG/KG     100                                    
                                                                                             MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          15           15           15           15                                     
  Early Deaths                                                                                                                      
    Dosing Accident                                    1                                                                            
    Moribund Sacrifice                                 1            1            3                                                  
  Survivors                                                                                                                         
    Terminal Sacrifice                                13           14           12           14                                     
    Natural Death                                                                             1                                     
                                                                                                                                    
  Animals Examined Microscopically                    15           15           15           15                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Esophagus                                          (1)                                                                           
      Inflammation                                     1 [2.0]                                                                      
   Liver                                              (15)         (15)         (15)         (15)                                   
      Cyst                                                                                    1 [2.0]                               
      Hematopoietic Cell Proliferation                              1 [2.0]                                                         
      Inflammation                                     6 [1.0]      7 [1.0]      9 [1.0]      8 [1.0]                               
      Necrosis                                         1 [1.0]                   1 [1.0]                                            
      Hepatocyte, Fatty Change                         1 [1.0]                                                                      
      Hepatocyte, Vacuolization Cytoplasmic            3 [1.3]      1 [1.0]      3 [1.0]      3 [1.0]                               
   Mesentery                                          (1)                       (1)                                                 
      Fat, Necrosis                                    1 [4.0]                   1 [3.0]                                            
   Stomach, Forestomach                               (15)         (15)         (15)         (15)                                   
      Hyperkeratosis                                   1 [1.0]                                                                      
   Tooth                                              (3)          (2)          (3)          (3)                                    
      Inflammation                                                                            1 [3.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (15)         (15)         (15)         (15)                                   
      Hypertrophy                                      6 [1.3]      8 [1.1]      5 [1.0]      7 [1.0]                               
      Subcapsular, Hyperplasia                                      2 [1.0]                                                         
   Pituitary Gland                                    (15)         (15)         (15)         (15)                                   
      Cyst                                             2 [1.0]      2 [1.5]      1 [2.0]      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    5                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/11/04    
Route: GAVAGE                                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                    Time: 08:49:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE                 0 MG/KG      25 MG/KG     50 MG/KG     100                                    
                                                                                             MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
ENDOCRINE SYSTEM - CONT                                                                                                             
   Thyroid Gland                                      (15)         (15)         (15)         (15)                                   
      Cyst                                             2 [1.0]      2 [1.0]                   1 [2.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (15)         (15)         (15)         (15)                                   
      Inflammation                                                               1 [1.0]                                            
   Preputial Gland                                                              (2)                                                 
      Cyst                                                                       1 [2.0]                                            
      Duct, Ectasia                                                              1 [2.0]                                            
   Testes                                             (15)         (15)         (15)         (15)                                   
      Germinal Epithelium, Degeneration                1 [2.0]      4 [2.5]      1 [2.0]                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (15)         (15)         (15)         (15)                                   
      Atrophy                                                                                 1 [2.0]                               
      Hyperplasia                                      1 [1.0]                                2 [1.0]                               
      Infiltration Cellular, Plasma Cell                            2 [2.0]                                                         
   Lymph Node, Mesenteric                             (15)         (14)         (15)         (15)                                   
      Atrophy                                          1 [3.0]                                1 [2.0]                               
   Spleen                                             (15)         (15)         (15)         (15)                                   
      Hematopoietic Cell Proliferation                 1 [1.0]      1 [2.0]      2 [1.0]                                            
      Lymphoid Follicle, Atrophy                       1 [2.0]                   1 [2.0]                                            
   Thymus                                             (14)         (15)         (15)         (15)                                   
      Atrophy                                          2 [2.0]      1 [2.0]      3 [2.7]      2 [2.5]                               
      Cyst                                             7 [1.0]      5 [1.0]      4 [1.0]      8 [1.0]                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 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: 97013-08         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT18  
Study Type: SUBCHRON 26-WEEK                         WITH AVERAGE SEVERITY GRADES[b]                              Date: 06/11/04    
Route: GAVAGE                                  WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                    Time: 08:49:14    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE                 0 MG/KG      25 MG/KG     50 MG/KG     100                                    
                                                                                             MG/KG                                  
____________________________________________________________________________________________________________________________________
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (15)         (15)         (15)         (15)                                   
      Edema                                                         1 [2.0]                                                         
      Inflammation                                                                            1 [1.0]                               
      Alveolar Epithelium, Hyperplasia                              1 [2.0]                                                         
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (15)         (15)         (15)         (15)                                   
      Casts Protein                                    3 [1.3]                                6 [1.3]                               
      Cyst                                                          1 [1.0]                                                         
      Hydronephrosis                                                1 [1.0]                                                         
      Nephropathy                                      2 [1.0]      8 [1.0]      3 [1.0]      4 [1.0]                               
      Artery, Inflammation                                          1 [1.0]                                                         
      Renal Tubule, Degeneration                                                              4 [1.0]                               
      Renal Tubule, Dilatation                         2 [1.0]      1 [1.0]      5 [1.0]      4 [1.0]                               
      Renal Tubule, Hypertrophy                                                  4 [1.0]      1 [1.0]                               
      Renal Tubule, Necrosis                                                                  1 [2.0]                               
                                                                                                                                    
                                                                                                                                    
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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