TDMS Study 97013-92 Pathology Tables
NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 12/08/03 Route: SKIN APPLICATION Time: 14:28:00 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 Page 1 NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 12/08/03 Route: SKIN APPLICATION Time: 14:28:00 ____________________________________________________________________________________________________________________________________ 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 (22%) 2 (20%) 2 (20%) 2 (20%) Inflammation, Chronic Active 7 (78%) 9 (90%) 10 (100%) 9 (90%) Necrosis 2 (22%) 1 (10%) 1 (10%) 2 (20%) Hepatocyte, Fatty Change 1 (11%) Hepatocyte, Vacuolization Cytoplasmic 7 (78%) 4 (40%) 7 (70%) 8 (80%) Stomach, Forestomach (9) (10) (10) (10) Epithelium, Hyperkeratosis 1 (11%) 1 (10%) 2 (20%) 1 (10%) Epithelium, Hyperplasia 1 (11%) 1 (10%) 3 (30%) 2 (20%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (9) (10) (10) (10) Accessory Adrenal Cortical Nodule 2 (22%) 2 (20%) 2 (20%) 4 (40%) Subcapsular, Hyperplasia 4 (44%) 7 (70%) 7 (70%) 3 (30%) Pituitary Gland (9) (10) (10) (10) Pars Distalis, Hypertrophy 1 (10%) Pars Distalis, Inflammation, Chronic Active 1 (11%) Thyroid Gland (9) (10) (10) (10) Infiltration Cellular, Lymphocyte 2 (20%) 5 (50%) 10 (100%) Follicle, Depletion Secretory 5 (56%) 8 (80%) 10 (100%) 10 (100%) Follicular Cell, Hypertrophy 1 (11%) 9 (90%) 9 (90%) 10 (100%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 12/08/03 Route: SKIN APPLICATION Time: 14:28:00 ____________________________________________________________________________________________________________________________________ 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 (11%) 4 (40%) 2 (20%) 5 (50%) Inflammation, Chronic Active 1 (11%) 1 (10%) Pigmentation, Hemosiderin 1 (10%) Corpus Luteum, Degeneration 1 (10%) Thecal Cell, Hyperplasia 1 (10%) Uterus (9) (10) (10) (10) Endometrium, Hyperplasia, Cystic 8 (89%) 7 (70%) 8 (80%) 10 (100%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (9) (10) (10) (10) Hyperplasia, Lymphoid 1 (11%) 3 (30%) 2 (20%) 2 (20%) Spleen (9) (10) (10) (10) Atrophy 1 (11%) 1 (10%) Hematopoietic Cell Proliferation 3 (33%) 6 (60%) 8 (80%) 8 (80%) Thymus (8) (10) (10) (10) Atrophy 1 (13%) 1 (10%) 2 (20%) 1 (10%) Cyst 1 (10%) 2 (20%) 5 (50%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (9) (10) (10) (10) Inflammation, Chronic Active 1 (10%) Ulcer 1 (10%) Epidermis, Hyperplasia, Focal 2 (22%) 2 (20%) 6 (60%) 3 (30%) Site of Application - Dermis, Cyst Epithelial Inclusion 1 (10%) Site of Application - Epidermis, Hyperplasia 1 (10%) Subcutaneous Tissue, Cyst Epithelial Inclusion 1 (10%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 12/08/03 Route: SKIN APPLICATION Time: 14:28:00 ____________________________________________________________________________________________________________________________________ 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 (10%) 1 (10%) Metaplasia, Osseous 1 (10%) Perivascular, Infiltration Cellular, Lymphocyte 1 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM Eye (1) Cornea, Inflammation, Chronic Active 1 (100%) Zymbal's Gland (2) Cyst 1 (50%) Inflammation, Chronic Active 1 (50%) ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (9) (10) (10) (10) Mineralization 1 (10%) Nephropathy 5 (56%) 6 (60%) 8 (80%) 10 (100%) Artery, Inflammation, Chronic Active 1 (10%) Cortex, Cyst 1 (11%) Renal Tubule, Hypertrophy 4 (40%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 12/08/03 Route: SKIN APPLICATION Time: 14:28:00 ____________________________________________________________________________________________________________________________________ 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 (10%) 1 (10%) 1 (10%) Inflammation, Chronic Active 8 (80%) 8 (80%) 6 (60%) 6 (60%) Necrosis 2 (20%) Hepatocyte, Fatty Change 1 (10%) Hepatocyte, Vacuolization Cytoplasmic 5 (50%) 8 (80%) 6 (60%) 2 (20%) Mesentery (1) (2) Fat, Fibrosis 1 (100%) 1 (50%) Fat, Inflammation, Chronic Active 1 (100%) 2 (100%) Fat, Necrosis 1 (100%) 2 (100%) Stomach, Forestomach (10) (10) (10) (10) Epithelium, Hyperkeratosis 2 (20%) 1 (10%) Epithelium, Hyperplasia 2 (20%) 1 (10%) Tooth (2) (3) (3) (2) Abscess, Focal 1 (50%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (10) (10) (10) (10) Accessory Adrenal Cortical Nodule 2 (20%) 1 (10%) Hypertrophy 6 (60%) 5 (50%) 6 (60%) 6 (60%) Pituitary Gland (9) (10) (10) (10) Pars Distalis, Cyst 3 (33%) 3 (30%) 1 (10%) 3 (30%) Thyroid Gland (10) (10) (10) (10) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 12/08/03 Route: SKIN APPLICATION Time: 14:28:00 ____________________________________________________________________________________________________________________________________ TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 64 MG/KG 128 256 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Infiltration Cellular, Lymphocyte 2 (20%) 1 (10%) Follicle, Cyst 1 (10%) Follicle, Depletion Secretory 8 (80%) 7 (70%) 9 (90%) 9 (90%) Follicular Cell, Hypertrophy 9 (90%) 8 (80%) 8 (80%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Epididymis (10) (10) (10) (10) Cyst 2 (20%) 2 (20%) Degeneration 1 (10%) 2 (20%) 3 (30%) 5 (50%) Inflammation, Chronic Active 3 (30%) 2 (20%) Testes (10) (10) (10) (10) Cyst 1 (10%) 1 (10%) 2 (20%) Mineralization 1 (10%) Bilateral, Germinal Epithelium, Degeneration 1 (10%) 1 (10%) 2 (20%) Germinal Epithelium, Degeneration 1 (10%) 2 (20%) 3 (30%) 6 (60%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (10) (10) (10) (10) Hyperplasia, Lymphoid 1 (10%) 3 (30%) Spleen (10) (10) (10) (10) Hematopoietic Cell Proliferation 3 (30%) 2 (20%) 2 (20%) 3 (30%) Hyperplasia, Lymphoid 1 (10%) Thymus (10) (10) (10) (9) Atrophy 3 (30%) 2 (20%) 4 (40%) 3 (33%) Cyst 7 (70%) 1 (10%) 3 (33%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (10) (10) (10) (10) Hyperkeratosis 1 (10%) 1 (10%) Epidermis, Hyperplasia, Focal 4 (40%) 2 (20%) 1 (10%) 2 (20%) Site of Application - Epidermis, Hyperplasia, Focal 1 (10%) 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 97013-92 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 12/08/03 Route: SKIN APPLICATION Time: 14:28:00 ____________________________________________________________________________________________________________________________________ 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 (10%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (10) (10) (10) (10) Inflammation, Chronic Active 2 (20%) 1 (10%) 1 (10%) Alveolar Epithelium, Hyperplasia 1 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) (10) Mineralization 1 (10%) Nephropathy 7 (70%) 10 (100%) 9 (90%) 10 (100%) Cortex, Cyst 3 (30%) 1 (10%) Glomerulus, Inflammation, Membranoproliferative 1 (10%) 1 (10%) 1 (10%) Papilla, Mineralization 1 (10%) Pelvis, Dilatation 1 (10%) Renal Tubule, Hypertrophy 2 (20%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------