TDMS Study 97013-11 Pathology Tables
NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/04
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 09:21:32
FINAL#1 MICE
Facility: Battelle Columbus Laboratory
Chemical CAS #: 7789-38-0
Lock Date: 07/30/01
Cage Range: All
Reasons For Removal: All
Removal Date Range: All
Treatment Groups: Include 001 0 MG/KG
Include 002 0 MG/KG
Include 003 64 MG/KG
Include 004 64 MG/KG
Include 005 128 MG/KG
Include 006 128 MG/KG
Include 007 256 MG/KG
Include 008 256 MG/KG
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 1
NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/04
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 09:21:32
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 15 15 15 15
Early Deaths
Moribund Sacrifice 2 4 1 3
Natural Death 2 1 3 1
Survivors
Terminal Sacrifice 11 10 11 11
Animals Examined Microscopically 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Intestine Large, Rectum (1) (2) (1)
Anus, Hyperplasia 1 [1.0]
Liver (15) (15) (15) (15)
Hematopoietic Cell Proliferation 2 [1.0] 2 [1.0] 2 [1.0] 3 [1.0]
Inflammation, Chronic Active 13 [1.0] 12 [1.0] 12 [1.0] 12 [1.1]
Thrombosis 1 [3.0]
Hepatocyte, Degeneration 1 [2.0]
Hepatocyte, Fatty Change 1 [1.0]
Hepatocyte, Necrosis 1 [1.0] 2 [1.0] 1 [1.0] 1 [2.0]
Hepatocyte, Vacuolization Cytoplasmic 3 [1.3] 4 [1.3] 3 [1.3] 3 [1.0]
Salivary Glands (1)
Atrophy 1 [1.0]
Inflammation, Chronic Active 1 [1.0]
Stomach, Forestomach (15) (15) (15) (15)
Epithelium, Hyperkeratosis 1 [1.0] 2 [2.0] 1 [2.0] 1 [2.0]
Epithelium, Hyperplasia 2 [1.0] 2 [2.0] 1 [2.0] 2 [2.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (15) (15)
Accessory Adrenal Cortical Nodule 3 [1.0] 3 [1.0] 1 [1.0] 1 [1.0]
Subcapsular, Hyperplasia 4 [1.0] 3 [1.0] 5 [1.0] 3 [1.0]
Pituitary Gland (15) (15) (15) (15)
Pars Distalis, Cyst 2 [1.0] 1 [1.0] 2 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 2
NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/04
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 09:21:32
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM - CONT
Pars Intermedia, Cyst 1 [1.0]
Thyroid Gland (15) (15) (15) (15)
Ectopic Thymus 1 [1.0]
Infiltration Cellular, Lymphocyte 6 [1.0] 3 [1.0] 12 [1.3]
Follicle, Cyst 1 [1.0] 1 [2.0]
Follicle, Depletion Secretory 6 [1.2] 11 [1.2] 13 [1.5] 14 [2.6]
Follicular Cell, Hypertrophy 1 [1.0] 9 [1.0] 12 [1.9] 13 [2.8]
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Ovary (15) (15) (15) (15)
Atrophy 1 [3.0]
Cyst 1 [2.0] 3 [1.0]
Hemorrhage 1 [2.0]
Pigmentation 1 [3.0]
Uterus (15) (15) (15) (15)
Endometrium, Hyperplasia, Cystic 11 [1.0] 9 [1.3] 10 [1.3] 10 [1.2]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node (2) (2)
Mediastinal, Hyperplasia, Lymphoid 1 [2.0]
Lymph Node, Mandibular (15) (14) (14) (15)
Hyperplasia, Lymphoid 4 [2.3] 2 [3.5] 2 [2.0] 3 [3.0]
Lymph Node, Mesenteric (14) (14) (13) (15)
Hyperplasia, Lymphoid 1 [3.0]
Spleen (15) (15) (15) (15)
Atrophy 1 [2.0] 1 [3.0] 1 [2.0]
Hematopoietic Cell Proliferation 3 [1.7] 5 [1.4] 9 [1.9] 10 [2.1]
Thymus (15) (14) (15) (15)
Atrophy 1 [3.0] 3 [3.0] 4 [2.8] 2 [2.5]
Cyst 2 [1.0] 4 [1.0] 2 [1.0] 3 [1.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 3
NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/04
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 09:21:32
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM - CONT
Skin (15) (15) (15) (15)
Hyperkeratosis 1 [4.0]
Inflammation, Chronic Active 1 [4.0] 1 [2.0] 1 [4.0]
Inflammation, Suppurative 1 [3.0]
Ulcer 1 [4.0]
Epidermis, Hyperplasia, Focal 2 [2.0] 3 [2.3] 3 [3.3] 1 [3.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
Bone (1)
Fracture 1
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15)
Inflammation, Chronic Active 2 [1.0]
Thrombosis 1 [1.0]
Alveolar Epithelium, Hyperplasia 1 [1.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (15) (15) (15)
Nephropathy 8 [1.0] 7 [1.0] 13 [1.0] 15 [1.0]
Renal Tubule, Dilatation 1 [1.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 4
NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/04
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 09:21:32
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
DISPOSITION SUMMARY
Animals Initially In Study 15 15 15 15
Early Deaths
Moribund Sacrifice 2 1
Natural Death 1 3 2
Survivors
Terminal Sacrifice 12 11 13 15
Animals Examined Microscopically 15 15 15 15
____________________________________________________________________________________________________________________________________
ALIMENTARY SYSTEM
Liver (15) (15) (15) (15)
Hematopoietic Cell Proliferation 1 [1.0] 1 [1.0]
Inflammation, Chronic Active 10 [1.0] 6 [1.0] 9 [1.0] 11 [1.0]
Hepatocyte, Necrosis 1 [2.0] 2 [2.0]
Hepatocyte, Vacuolization Cytoplasmic 6 [1.2] 4 [1.3] 3 [1.0] 6 [1.8]
Mesentery (1) (1)
Fat, Necrosis 1 [4.0] 1 [4.0]
Stomach, Forestomach (15) (15) (15) (15)
Epithelium, Hyperplasia 1 [2.0] 2 [1.5] 1 [3.0]
____________________________________________________________________________________________________________________________________
CARDIOVASCULAR SYSTEM
None
____________________________________________________________________________________________________________________________________
ENDOCRINE SYSTEM
Adrenal Cortex (15) (15) (15) (15)
Accessory Adrenal Cortical Nodule 1 [1.0]
Hypertrophy 8 [1.5] 4 [1.5] 1 [1.0] 3 [1.3]
Subcapsular, Hyperplasia 1 [1.0]
Pituitary Gland (15) (14) (15) (15)
Pars Distalis, Cyst 3 [1.0] 4 [1.0] 3 [1.0]
Pars Distalis, Hyperplasia 1 [1.0]
Thyroid Gland (15) (15) (15) (15)
Infiltration Cellular, Lymphocyte 1 [1.0]
Follicle, Depletion Secretory 7 [1.0] 4 [1.0] 5 [1.0] 11 [1.1]
Follicular Cell, Hypertrophy 7 [1.0] 10 [1.3] 14 [1.4]
____________________________________________________________________________________________________________________________________
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 5
NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/04
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 09:21:32
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
GENERAL BODY SYSTEM
None
____________________________________________________________________________________________________________________________________
GENITAL SYSTEM
Epididymis (15) (15) (15) (15)
Degeneration 1 [4.0] 2 [4.0]
Testes (15) (15) (15) (15)
Cyst 1 [3.0] 1 [2.0]
Germinal Epithelium, Degeneration 2 [2.0] 2 [2.0] 3 [1.7]
____________________________________________________________________________________________________________________________________
HEMATOPOIETIC SYSTEM
Lymph Node, Mandibular (15) (15) (15) (15)
Necrosis, Lymphoid 1 [2.0] 1 [1.0]
Lymph Node, Mesenteric (15) (15) (15) (15)
Necrosis, Lymphoid 1 [2.0]
Spleen (15) (15) (15) (15)
Atrophy 1 [3.0]
Hematopoietic Cell Proliferation 1 [2.0] 2 [2.0]
Thymus (14) (15) (15) (15)
Atrophy 1 [2.0] 4 [2.5] 1 [3.0] 4 [2.5]
Cyst 2 [1.0] 2 [1.5] 2 [1.0] 5 [1.0]
Ectopic Parathyroid Gland 1 [1.0]
Ectopic Thyroid 1 [2.0]
____________________________________________________________________________________________________________________________________
INTEGUMENTARY SYSTEM
Skin (15) (15) (15) (15)
Hyperkeratosis 2 [2.0] 3 [1.7] 4 [2.0]
Hyperkeratosis, Focal 1 [2.0]
Inflammation, Chronic Active 1 [1.0]
Epidermis, Hyperplasia, Focal 3 [2.0] 2 [1.5] 3 [1.3] 4 [1.8]
Site of Application - Epidermis, Hyperplasia,
Focal 1 [1.0]
____________________________________________________________________________________________________________________________________
MUSCULOSKELETAL SYSTEM
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 6
NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT18
Study Type: SUBCHRON 26-WEEK WITH AVERAGE SEVERITY GRADES[b] Date: 06/18/04
Route: SKIN APPLICATION WATER DISINFECTION MODEL (SODIUM BROMATE) Time: 09:21:32
____________________________________________________________________________________________________________________________________
TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 64 MG/KG 128 256
MG/KG MG/KG
____________________________________________________________________________________________________________________________________
None
____________________________________________________________________________________________________________________________________
NERVOUS SYSTEM
None
____________________________________________________________________________________________________________________________________
RESPIRATORY SYSTEM
Lung (15) (15) (15) (15)
Inflammation, Chronic Active 1 [1.0]
Pigmentation 1 [1.0]
Thrombosis 1 [3.0]
Alveolar Epithelium, Hyperplasia 1 [1.0]
Alveolus, Infiltration Cellular, Histiocyte 1 [1.0]
____________________________________________________________________________________________________________________________________
SPECIAL SENSES SYSTEM
None
____________________________________________________________________________________________________________________________________
URINARY SYSTEM
Kidney (15) (15) (15) (15)
Nephropathy 8 [1.0] 8 [1.1] 14 [1.0] 14 [1.1]
Artery, Inflammation, Chronic Active 1 [2.0]
Renal Tubule, Dilatation 1 [2.0] 2 [1.5]
Urethra (1)
Bulbourethral Gland, Cyst 1 [4.0]
a Number of animals examined microscopically at site and number of animals with lesion
b Average severity grade (1-minimal;2-mild;3-moderate;4-marked)
Page 7
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