TDMS Study 97013-92 Pathology Tables
NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 12/08/03
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 14:33:25
FINAL#1 MICE
Facility: Battelle Columbus Laboratory
Chemical CAS #: 7789-38-0
Lock Date: 07/30/01
Cage Range: All
Reasons For Removal: 25019 Moribund Sacrifice 25020 Natural Death
25021 Terminal Sacrifice
Removal Date Range: All
Treatment Groups: Include All
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 1
NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 12/08/03
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 14:33:25
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 10 10 10 10
Early Deaths
Moribund Sacrifice 1 1 2 1
Natural Death 1 2 1
Survivors
Terminal Sacrifice 7 7 8 8
Animals Examined Microscopically 9 10 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (9) (10) (10) (10)
Hematopoietic Cell Proliferation 2 [1.0] 2 [1.0] 2 [1.0] 2 [1.0]
Inflammation, Chronic Active 7 [1.0] 9 [1.0] 10 [1.2] 9 [1.1]
Necrosis 2 [1.0] 1 [1.0] 1 [1.0] 2 [1.0]
Hepatocyte, Fatty Change 1 [1.0]
Hepatocyte, Vacuolization Cytoplasmic 7 [1.1] 4 [1.0] 7 [1.1] 8 [1.1]
Stomach, Forestomach (9) (10) (10) (10)
Epithelium, Hyperkeratosis 1 [1.0] 1 [2.0] 2 [2.0] 1 [1.0]
Epithelium, Hyperplasia 1 [3.0] 1 [3.0] 3 [2.3] 2 [2.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (9) (10) (10) (10)
Accessory Adrenal Cortical Nodule 2 [2.0] 2 [2.5] 2 [1.5] 4 [1.3]
Subcapsular, Hyperplasia 4 [1.0] 7 [1.0] 7 [1.0] 3 [1.0]
Pituitary Gland (9) (10) (10) (10)
Pars Distalis, Hypertrophy 1 [2.0]
Pars Distalis, Inflammation, Chronic Active 1 [3.0]
Thyroid Gland (9) (10) (10) (10)
Infiltration Cellular, Lymphocyte 2 [1.5] 5 [1.2] 10 [1.4]
Follicle, Depletion Secretory 5 [1.2] 8 [1.5] 10 [2.7] 10 [3.5]
Follicular Cell, Hypertrophy 1 [1.0] 9 [1.6] 9 [2.9] 10 [3.3]
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 2
NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 12/08/03
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 14:33:25
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (9) (10) (10) (10)
Cyst 1 [2.0] 4 [1.0] 2 [2.0] 5 [2.2]
Inflammation, Chronic Active 1 [3.0] 1 [3.0]
Pigmentation, Hemosiderin 1 [3.0]
Corpus Luteum, Degeneration 1 [4.0]
Thecal Cell, Hyperplasia 1 [3.0]
Uterus (9) (10) (10) (10)
Endometrium, Hyperplasia, Cystic 8 [1.9] 7 [2.0] 8 [1.5] 10 [1.4]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (9) (10) (10) (10)
Hyperplasia, Lymphoid 1 [3.0] 3 [2.7] 2 [2.0] 2 [2.5]
Spleen (9) (10) (10) (10)
Atrophy 1 [3.0] 1 [3.0]
Hematopoietic Cell Proliferation 3 [2.0] 6 [1.8] 8 [1.8] 8 [1.8]
Thymus (8) (10) (10) (10)
Atrophy 1 [4.0] 1 [4.0] 2 [3.0] 1 [3.0]
Cyst 1 [1.0] 2 [1.0] 5 [1.4]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (9) (10) (10) (10)
Inflammation, Chronic Active 1 [2.0]
Ulcer 1 [4.0]
Epidermis, Hyperplasia, Focal 2 [2.5] 2 [2.0] 6 [3.2] 3 [2.0]
Site of Application - Dermis, Cyst
Epithelial Inclusion 1 [3.0]
Site of Application - Epidermis, Hyperplasia 1 [1.0]
Subcutaneous Tissue, Cyst Epithelial
Inclusion 1 [3.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 3
NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 12/08/03
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 14:33:25
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (9) (10) (10) (10)
Inflammation, Chronic Active 1 [2.0] 1 [1.0]
Metaplasia, Osseous 1 [1.0]
Perivascular, Infiltration Cellular,
Lymphocyte 1 [1.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
Eye (1)
Cornea, Inflammation, Chronic Active 1 [2.0]
Zymbal's Gland (2)
Cyst 1 [4.0]
Inflammation, Chronic Active 1 [4.0]
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (9) (10) (10) (10)
Mineralization 1 [1.0]
Nephropathy 5 [1.0] 6 [1.0] 8 [1.0] 10 [1.3]
Artery, Inflammation, Chronic Active 1 [2.0]
Cortex, Cyst 1 [2.0]
Renal Tubule, Hypertrophy 4 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 4
NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 12/08/03
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 14:33:25
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 10 10 10 10
Early Deaths
Moribund Sacrifice 1 2
Natural Death 1 2 2
Survivors
Terminal Sacrifice 8 8 8 8
Animals Examined Microscopically 10 10 10 10
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (10) (10) (10) (10)
Hematopoietic Cell Proliferation 1 [1.0] 1 [1.0] 1 [1.0]
Inflammation, Chronic Active 8 [1.0] 8 [1.0] 6 [1.0] 6 [1.2]
Necrosis 2 [1.0]
Hepatocyte, Fatty Change 1 [1.0]
Hepatocyte, Vacuolization Cytoplasmic 5 [1.2] 8 [1.1] 6 [1.0] 2 [1.0]
Mesentery (1) (2)
Fat, Fibrosis 1 [2.0] 1 [3.0]
Fat, Inflammation, Chronic Active 1 [2.0] 2 [2.0]
Fat, Necrosis 1 [4.0] 2 [4.0]
Stomach, Forestomach (10) (10) (10) (10)
Epithelium, Hyperkeratosis 2 [1.0] 1 [2.0]
Epithelium, Hyperplasia 2 [1.5] 1 [2.0]
Tooth (2) (3) (3) (2)
Abscess, Focal 1
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (10) (10) (10) (10)
Accessory Adrenal Cortical Nodule 2 [1.5] 1 [1.0]
Hypertrophy 6 [1.5] 5 [1.2] 6 [1.7] 6 [1.3]
Pituitary Gland (9) (10) (10) (10)
Pars Distalis, Cyst 3 [1.0] 3 [1.0] 1 [1.0] 3 [1.0]
Thyroid Gland (10) (10) (10) (10)
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 5
NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 12/08/03
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 14:33:25
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Infiltration Cellular, Lymphocyte 2 [1.0] 1 [1.0]
Follicle, Cyst 1 [2.0]
Follicle, Depletion Secretory 8 [1.0] 7 [1.0] 9 [1.3] 9 [1.4]
Follicular Cell, Hypertrophy 9 [1.0] 8 [1.5] 8 [1.9]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (10) (10) (10) (10)
Cyst 2 2
Degeneration 1 [4.0] 2 [3.0] 3 [4.0] 5 [3.8]
Inflammation, Chronic Active 3 [2.0] 2 [1.5]
Testes (10) (10) (10) (10)
Cyst 1 [2.0] 1 [2.0] 2 [2.5]
Mineralization 1 [1.0]
Bilateral, Germinal Epithelium, Degeneration 1 [3.0] 1 [3.0] 2 [3.0]
Germinal Epithelium, Degeneration 1 [3.0] 2 [1.5] 3 [3.0] 6 [2.8]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (10) (10) (10) (10)
Hyperplasia, Lymphoid 1 [3.0] 3 [3.0]
Spleen (10) (10) (10) (10)
Hematopoietic Cell Proliferation 3 [2.0] 2 [2.0] 2 [2.5] 3 [1.7]
Hyperplasia, Lymphoid 1 [2.0]
Thymus (10) (10) (10) (9)
Atrophy 3 [2.0] 2 [2.5] 4 [3.3] 3 [2.3]
Cyst 7 [1.0] 1 [2.0] 3 [1.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (10) (10) (10) (10)
Hyperkeratosis 1 [2.0] 1 [2.0]
Epidermis, Hyperplasia, Focal 4 [2.5] 2 [2.0] 1 [2.0] 2 [2.5]
Site of Application - Epidermis, Hyperplasia,
Focal 1 [1.0] 1 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 6
NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: 26-39 WEEKS WITH AVERAGE SEVERITY GRADES[b] Date: 12/08/03
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 14:33:25
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Subcutaneous Tissue, Inflammation, Chronic
Active 1 [4.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (10) (10) (10) (10)
Inflammation, Chronic Active 2 [1.0] 1 [1.0] 1 [2.0]
Alveolar Epithelium, Hyperplasia 1 [1.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (10) (10) (10) (10)
Mineralization 1 [1.0]
Nephropathy 7 [1.0] 10 [1.1] 9 [1.1] 10 [1.2]
Cortex, Cyst 3 [1.7] 1 [1.0]
Glomerulus, Inflammation,
Membranoproliferative 1 [3.0] 1 [4.0] 1 [1.0]
Papilla, Mineralization 1 [1.0]
Pelvis, Dilatation 1 [1.0]
Renal Tubule, Hypertrophy 2 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 7
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