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TDMS Study 97013-97 Pathology Tables

NTP Experiment-Test: 97013-97         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03
Study Type: 26-39 WEEKS                      WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                      Date: 11/04/03
Route: GAVAGE                                                                                                     Time: 12:00:46

                                                         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 All


































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

                                                              Page   1


NTP Experiment-Test: 97013-97         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                      WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                      Date: 11/04/03    
Route: GAVAGE                                                                                                     Time: 12:00:46    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            0 MG/KG      25 MG/KG     50 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          10           10           10           10                                     
  Early Deaths                                                                                                                      
    Natural Death                                      2            1            1            1                                     
    Moribund Sacrifice                                 1                                      2                                     
  Survivors                                                                                                                         
    Terminal Sacrifice                                 7            9            9            7                                     
                                                                                                                                    
  Animals Examined Microscopically                    10           10           10           10                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Gallbladder                                                     (1)                                                              
      Inflammation, Chronic Active                                  1 (100%)                                                        
   Intestine Large, Colon                             (10)         (10)         (10)         (10)                                   
      Inflammation                                     1 (10%)                                                                      
   Intestine Large, Cecum                             (10)         (10)         (10)         (10)                                   
      Edema                                            1 (10%)                                                                      
      Inflammation                                     1 (10%)                                                                      
   Intestine Small, Ileum                             (10)         (10)         (10)         (10)                                   
      Ulcer                                            1 (10%)                                                                      
   Liver                                              (10)         (10)         (10)         (10)                                   
      Cytomegaly                                                                              1 (10%)                               
      Hematopoietic Cell Proliferation                 1 (10%)      2 (20%)                   3 (30%)                               
      Inflammation                                     8 (80%)      9 (90%)     10 (100%)     6 (60%)                               
      Necrosis                                         2 (20%)      2 (20%)      1 (10%)      1 (10%)                               
      Hepatocyte, Fatty Change                                      2 (20%)      8 (80%)      5 (50%)                               
      Hepatocyte, Vacuolization Cytoplasmic            6 (60%)      9 (90%)     10 (100%)     9 (90%)                               
   Mesentery                                          (1)                                                                           
      Hemorrhage                                       1 (100%)                                                                     
      Artery, Inflammation                             1 (100%)                                                                     
      Artery, Thrombosis                               1 (100%)                                                                     
   Stomach, Forestomach                               (10)         (10)         (10)         (10)                                   
      Hyperkeratosis                                   1 (10%)      2 (20%)      4 (40%)      4 (40%)                               
      Epithelium, Hyperplasia                          1 (10%)      2 (20%)      4 (40%)      4 (40%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    2                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-97         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                      WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                      Date: 11/04/03    
Route: GAVAGE                                                                                                     Time: 12:00:46    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            0 MG/KG      25 MG/KG     50 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (10)         (10)         (10)         (10)                                   
      Hematopoietic Cell Proliferation                 1 (10%)                                1 (10%)                               
      Subcapsular, Hyperplasia                         5 (50%)      6 (60%)      4 (40%)      7 (70%)                               
   Islets, Pancreatic                                                                        (1)                                    
      Hyperplasia                                                                             1 (100%)                              
   Pituitary Gland                                    (10)         (10)         (10)         (10)                                   
      Cyst                                             2 (20%)      1 (10%)      1 (10%)                                            
   Thyroid Gland                                      (10)         (10)         (10)         (10)                                   
      Cyst                                             2 (20%)      5 (50%)      2 (20%)      2 (20%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Ovary                                              (10)         (10)         (10)         (10)                                   
      Amyloid Deposition                                                                      1 (10%)                               
      Atrophy                                                       1 (10%)                                                         
      Cyst                                             1 (10%)                   3 (30%)      1 (10%)                               
      Inflammation, Suppurative                                                  1 (10%)                                            
   Oviduct                                                                                   (1)                                    
      Inflammation, Suppurative                                                               1 (100%)                              
   Uterus                                             (10)         (10)         (10)         (10)                                   
      Inflammation                                                  1 (10%)                   1 (10%)                               
      Inflammation, Granulomatous                                                             1 (10%)                               
      Endometrium, Hyperplasia, Cystic                 7 (70%)     10 (100%)     9 (90%)      8 (80%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (10)         (10)         (10)         (9)                                    
      Hyperplasia                                                                1 (10%)                                            
      Infiltration Cellular, Plasma Cell               2 (20%)      1 (10%)                   2 (22%)                               
   Lymph Node, Mesenteric                             (10)         (10)         (10)         (10)                                   
      Atrophy                                                       1 (10%)                   1 (10%)                               
      Ectasia                                          1 (10%)                                                                      
   Spleen                                             (10)         (10)         (10)         (10)                                   
      Atrophy                                          2 (20%)                                1 (10%)                               
      Hematopoietic Cell Proliferation                 1 (10%)      2 (20%)                   5 (50%)                               
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    3                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-97         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                      WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                      Date: 11/04/03    
Route: GAVAGE                                                                                                     Time: 12:00:46    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            0 MG/KG      25 MG/KG     50 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
HEMATOPOIETIC SYSTEM - CONT                                                                                                         
   Thymus                                             (10)         (10)         (10)         (9)                                    
      Atrophy                                          2 (20%)      1 (10%)                   4 (44%)                               
      Cyst                                             3 (30%)      2 (20%)      5 (50%)      3 (33%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Mammary Gland                                                                             (1)                                    
      Inflammation, Granulomatous                                                             1 (100%)                              
   Skin                                               (6)          (5)          (7)          (7)                                    
      Hyperplasia                                      1 (17%)      3 (60%)                   2 (29%)                               
      Epidermis, Hyperplasia, Focal                                 1 (20%)      1 (14%)                                            
      Subcutaneous Tissue, Hemorrhage                                            1 (14%)                                            
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (10)         (10)         (10)         (10)                                   
      Inflammation                                                                            1 (10%)                               
      Perivascular, Inflammation                       2 (20%)                                1 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (10)         (10)         (10)         (10)                                   
      Amyloid Deposition                                                         1 (10%)                                            
      Casts Protein                                    1 (10%)      2 (20%)      6 (60%)                                            
      Cyst                                                                       1 (10%)                                            
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    4                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-97         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                      WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                      Date: 11/04/03    
Route: GAVAGE                                                                                                     Time: 12:00:46    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS FEMALE            0 MG/KG      25 MG/KG     50 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
URINARY SYSTEM - CONT                                                                                                               
      Infiltration Cellular, Lymphocyte                             1 (10%)                                                         
      Nephropathy                                      3 (30%)      4 (40%)                   5 (50%)                               
      Renal Tubule, Hypertrophy                                                               1 (10%)                               
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    5                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-97         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                      WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                      Date: 11/04/03    
Route: GAVAGE                                                                                                     Time: 12:00:46    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              0 MG/KG      25 MG/KG     50 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
DISPOSITION SUMMARY                                                                                                                 
                                                                                                                                    
  Animals Initially In Study                          10           10           10           10                                     
  Early Deaths                                                                                                                      
    Moribund Sacrifice                                 3            1            4            2                                     
    Accidently Killed                                  1                                                                            
    Dosing Accident                                                 3                                                               
  Survivors                                                                                                                         
    Terminal Sacrifice                                 6            6            6            8                                     
                                                                                                                                    
  Animals Examined Microscopically                    10           10           10           10                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ALIMENTARY SYSTEM                                                                                                                  
                                                                                                                                    
   Liver                                              (10)         (10)         (10)         (10)                                   
      Hematopoietic Cell Proliferation                 2 (20%)                   1 (10%)      1 (10%)                               
      Inflammation                                     7 (70%)      6 (60%)      8 (80%)      5 (50%)                               
      Necrosis                                                      2 (20%)                                                         
      Hepatocyte, Fatty Change                                                   2 (20%)                                            
      Hepatocyte, Vacuolization Cytoplasmic            6 (60%)      3 (30%)      7 (70%)      7 (70%)                               
      Hepatocyte, Vacuolization Cytoplasmic,                                                                                        
        Diffuse                                                     2 (20%)                                                         
   Stomach, Forestomach                               (10)         (10)         (10)         (10)                                   
      Hyperkeratosis                                   2 (20%)                   3 (30%)      2 (20%)                               
      Epithelium, Hyperplasia                          2 (20%)                   3 (30%)      2 (20%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 CARDIOVASCULAR SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 ENDOCRINE SYSTEM                                                                                                                   
                                                                                                                                    
   Adrenal Cortex                                     (10)         (10)         (10)         (10)                                   
      Hypertrophy                                      7 (70%)      3 (30%)      6 (60%)      7 (70%)                               
      Subcapsular, Hyperplasia                                      1 (10%)      2 (20%)                                            
   Pituitary Gland                                    (10)         (10)         (10)         (10)                                   
      Cyst                                             1 (10%)      1 (10%)                   1 (10%)                               
   Thyroid Gland                                      (10)         (10)         (10)         (10)                                   
      Cyst                                             2 (20%)                   1 (10%)      1 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                             Page    6                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-97         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                      WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                      Date: 11/04/03    
Route: GAVAGE                                                                                                     Time: 12:00:46    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              0 MG/KG      25 MG/KG     50 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 GENERAL BODY SYSTEM                                                                                                                
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 GENITAL SYSTEM                                                                                                                     
                                                                                                                                    
   Epididymis                                         (10)         (10)         (10)         (10)                                   
      Atrophy                                          1 (10%)                                1 (10%)                               
   Preputial Gland                                                              (1)                                                 
      Inflammation, Suppurative                                                  1 (100%)                                           
   Testes                                             (10)         (10)         (10)         (10)                                   
      Germinal Epithelium, Degeneration                2 (20%)      1 (10%)                   1 (10%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 HEMATOPOIETIC SYSTEM                                                                                                               
                                                                                                                                    
   Lymph Node, Mandibular                             (10)         (9)          (9)          (10)                                   
      Hematopoietic Cell Proliferation                 1 (10%)                                                                      
      Hyperplasia                                      1 (10%)      1 (11%)      1 (11%)      1 (10%)                               
      Infiltration Cellular, Plasma Cell               1 (10%)                   2 (22%)      1 (10%)                               
   Lymph Node, Mesenteric                             (10)         (10)         (10)         (10)                                   
      Hyperplasia                                      1 (10%)                                                                      
   Spleen                                             (10)         (10)         (10)         (10)                                   
      Atrophy                                                       1 (10%)                                                         
      Hematopoietic Cell Proliferation                 4 (40%)                   2 (20%)      1 (10%)                               
   Thymus                                             (9)          (10)         (10)         (10)                                   
      Atrophy                                          3 (33%)      3 (30%)      3 (30%)      2 (20%)                               
      Cyst                                             4 (44%)      2 (20%)      2 (20%)      3 (30%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 INTEGUMENTARY SYSTEM                                                                                                               
                                                                                                                                    
   Skin                                               (5)          (6)          (5)          (7)                                    
      Hyperplasia                                                   1 (17%)      2 (40%)      4 (57%)                               
      Inflammation                                                                            1 (14%)                               
      Subcutaneous Tissue, Fibrosis                                                           1 (14%)                               
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 MUSCULOSKELETAL SYSTEM                                                                                                             
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                             Page    7                                                              
                                                                                                                                   
NTP Experiment-Test: 97013-97         INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a)               Report: PEIRPT03  
Study Type: 26-39 WEEKS                      WATER DISINFECTION MODEL (BROMODICHLOROMETHANE)                      Date: 11/04/03    
Route: GAVAGE                                                                                                     Time: 12:00:46    
____________________________________________________________________________________________________________________________________
                                                                                                                                    
         TGAC (FVB/N) HEMIZYGOUS MALE              0 MG/KG      25 MG/KG     50 MG/KG     100                                       
                                                                                          MG/KG                                     
____________________________________________________________________________________________________________________________________
                                                                                                                                    
                                                                                                                                    
 NERVOUS SYSTEM                                                                                                                     
                                                                                                                                    
   Peripheral Nerve                                                             (1)                                                 
      Degeneration                                                               1 (100%)                                           
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 RESPIRATORY SYSTEM                                                                                                                 
                                                                                                                                    
   Lung                                               (10)         (10)         (10)         (10)                                   
      Inflammation                                     1 (10%)      1 (10%)      2 (20%)                                            
      Alveolar Epithelium, Hyperplasia                                                        1 (10%)                               
      Perivascular, Inflammation                                    1 (10%)      1 (10%)                                            
   Pleura                                                          (3)                                                              
      Inflammation, Suppurative                                     3 (100%)                                                        
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 SPECIAL SENSES SYSTEM                                                                                                              
                                                                                                                                    
   None                                                                                                                             
____________________________________________________________________________________________________________________________________
                                                                                                                                    
 URINARY SYSTEM                                                                                                                     
                                                                                                                                    
   Kidney                                             (10)         (10)         (10)         (10)                                   
      Casts Protein                                    3 (30%)      1 (10%)                   1 (10%)                               
      Cyst                                                          1 (10%)      2 (20%)                                            
      Nephropathy                                      3 (30%)      4 (40%)      6 (60%)      6 (60%)                               
      Glomerulus, Inflammation,                                                                                                     
        Membranoproliferative                                                    1 (10%)                                            
      Renal Tubule, Degeneration                                                              6 (60%)                               
      Renal Tubule, Dilatation                                      2 (20%)      2 (20%)      4 (40%)                               
                                                                                                                                    
                                                                                                                                    
a  Number of animals examined microscopically at site and number of animals with lesion                                             
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                                                                                                    
                                                             Page    8                                                              
                                                                                                                                   
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