TDMS Study 97013-97 Pathology Tables
NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 11/04/03
Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 12:03:30
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
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 1
NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 11/04/03
Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 12:03:30
____________________________________________________________________________________________________________________________________
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 [4.0]
Intestine Large, Colon (10) (10) (10) (10)
Inflammation 1 [1.0]
Intestine Large, Cecum (10) (10) (10) (10)
Edema 1 [4.0]
Inflammation 1 [2.0]
Intestine Small, Ileum (10) (10) (10) (10)
Ulcer 1 [3.0]
Liver (10) (10) (10) (10)
Cytomegaly 1 [3.0]
Hematopoietic Cell Proliferation 1 [1.0] 2 [1.5] 3 [1.0]
Inflammation 8 [1.1] 9 [1.1] 10 [1.0] 6 [1.0]
Necrosis 2 [1.0] 2 [1.0] 1 [2.0] 1 [1.0]
Hepatocyte, Fatty Change 2 [1.5] 8 [1.4] 5 [1.6]
Hepatocyte, Vacuolization Cytoplasmic 6 [1.3] 9 [1.3] 10 [1.1] 9 [1.7]
Mesentery (1)
Hemorrhage 1 [3.0]
Artery, Inflammation 1 [2.0]
Artery, Thrombosis 1 [2.0]
Stomach, Forestomach (10) (10) (10) (10)
Hyperkeratosis 1 [1.0] 2 [1.0] 4 [1.5] 4 [1.0]
Epithelium, Hyperplasia 1 [1.0] 2 [1.0] 4 [1.3] 4 [1.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR 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 2
NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 11/04/03
Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 12:03:30
____________________________________________________________________________________________________________________________________
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 [1.0] 1 [1.0]
Subcapsular, Hyperplasia 5 [1.0] 6 [1.0] 4 [1.0] 7 [1.0]
Islets, Pancreatic (1)
Hyperplasia 1 [2.0]
Pituitary Gland (10) (10) (10) (10)
Cyst 2 [1.0] 1 [1.0] 1 [1.0]
Thyroid Gland (10) (10) (10) (10)
Cyst 2 [1.0] 5 [1.2] 2 [1.0] 2 [1.5]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (10) (10) (10) (10)
Amyloid Deposition 1 [2.0]
Atrophy 1 [3.0]
Cyst 1 [2.0] 3 [2.0] 1 [2.0]
Inflammation, Suppurative 1 [2.0]
Oviduct (1)
Inflammation, Suppurative 1 [2.0]
Uterus (10) (10) (10) (10)
Inflammation 1 [1.0] 1 [2.0]
Inflammation, Granulomatous 1 [3.0]
Endometrium, Hyperplasia, Cystic 7 [1.7] 10 [1.6] 9 [1.6] 8 [1.6]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (10) (10) (10) (9)
Hyperplasia 1 [3.0]
Infiltration Cellular, Plasma Cell 2 [2.0] 1 [2.0] 2 [2.0]
Lymph Node, Mesenteric (10) (10) (10) (10)
Atrophy 1 [2.0] 1 [1.0]
Ectasia 1 [1.0]
Spleen (10) (10) (10) (10)
Atrophy 2 [2.0] 1 [1.0]
Hematopoietic Cell Proliferation 1 [2.0] 2 [1.5] 5 [1.8]
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: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 11/04/03
Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 12:03:30
____________________________________________________________________________________________________________________________________
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 [2.0] 1 [2.0] 4 [2.3]
Cyst 3 [1.0] 2 [1.0] 5 [1.2] 3 [1.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Mammary Gland (1)
Inflammation, Granulomatous 1 [4.0]
Skin (6) (5) (7) (7)
Hyperplasia 1 [2.0] 3 [2.0] 2 [2.0]
Epidermis, Hyperplasia, Focal 1 [2.0] 1 [1.0]
Subcutaneous Tissue, Hemorrhage 1 [1.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10) (10) (10)
Inflammation 1 [1.0]
Perivascular, Inflammation 2 [1.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (10) (10) (10) (10)
Amyloid Deposition 1 [1.0]
Casts Protein 1 [1.0] 2 [1.0] 6 [1.0]
Cyst 1 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 4
NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 11/04/03
Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 12:03:30
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
URINARY SYSTEM - CONT
Infiltration Cellular, Lymphocyte 1 [2.0]
Nephropathy 3 [1.0] 4 [1.0] 5 [1.0]
Renal Tubule, Hypertrophy 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: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 11/04/03
Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 12:03:30
____________________________________________________________________________________________________________________________________
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 [2.0] 1 [1.0] 1 [1.0]
Inflammation 7 [1.0] 6 [1.0] 8 [1.1] 5 [1.0]
Necrosis 2 [1.5]
Hepatocyte, Fatty Change 2 [1.5]
Hepatocyte, Vacuolization Cytoplasmic 6 [1.0] 3 [1.7] 7 [1.1] 7 [1.0]
Hepatocyte, Vacuolization Cytoplasmic,
Diffuse 2 [1.0]
Stomach, Forestomach (10) (10) (10) (10)
Hyperkeratosis 2 [1.0] 3 [1.0] 2 [1.0]
Epithelium, Hyperplasia 2 [1.0] 3 [1.3] 2 [1.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (10) (10) (10) (10)
Hypertrophy 7 [1.3] 3 [1.0] 6 [1.3] 7 [1.4]
Subcapsular, Hyperplasia 1 [1.0] 2 [1.0]
Pituitary Gland (10) (10) (10) (10)
Cyst 1 [1.0] 1 [1.0] 1 [1.0]
Thyroid Gland (10) (10) (10) (10)
Cyst 2 [1.5] 1 [1.0] 1 [1.0]
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 6
NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 11/04/03
Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 12:03:30
____________________________________________________________________________________________________________________________________
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 [2.0] 1 [2.0]
Preputial Gland (1)
Inflammation, Suppurative 1 [3.0]
Testes (10) (10) (10) (10)
Germinal Epithelium, Degeneration 2 [3.5] 1 [2.0] 1 [2.0]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (10) (9) (9) (10)
Hematopoietic Cell Proliferation 1 [2.0]
Hyperplasia 1 [2.0] 1 [1.0] 1 [2.0] 1 [1.0]
Infiltration Cellular, Plasma Cell 1 [2.0] 2 [2.5] 1 [2.0]
Lymph Node, Mesenteric (10) (10) (10) (10)
Hyperplasia 1 [1.0]
Spleen (10) (10) (10) (10)
Atrophy 1 [2.0]
Hematopoietic Cell Proliferation 4 [1.8] 2 [1.0] 1 [2.0]
Thymus (9) (10) (10) (10)
Atrophy 3 [1.3] 3 [3.0] 3 [2.7] 2 [2.0]
Cyst 4 [1.0] 2 [1.0] 2 [1.0] 3 [1.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (5) (6) (5) (7)
Hyperplasia 1 [2.0] 2 [1.5] 4 [1.8]
Inflammation 1 [2.0]
Subcutaneous Tissue, Fibrosis 1 [2.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL 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 7
NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 11/04/03
Route: GAVAGE WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Time: 12:03:30
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 25 MG/KG 50 MG/KG 100
MG/KG
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
Peripheral Nerve (1)
Degeneration 1 [1.0]
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10) (10) (10)
Inflammation 1 [1.0] 1 [1.0] 2 [1.5]
Alveolar Epithelium, Hyperplasia 1 [1.0]
Perivascular, Inflammation 1 [1.0] 1 [3.0]
Pleura (3)
Inflammation, Suppurative 3 [3.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (10) (10) (10) (10)
Casts Protein 3 [1.0] 1 [1.0] 1 [1.0]
Cyst 1 [1.0] 2 [1.5]
Nephropathy 3 [1.0] 4 [1.0] 6 [1.0] 6 [1.0]
Glomerulus, Inflammation,
Membranoproliferative 1 [1.0]
Renal Tubule, Degeneration 6 [1.7]
Renal Tubule, Dilatation 2 [1.0] 2 [1.0] 4 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 8
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