TDMS Study 97013-11 Pathology Tables
NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 06/18/04 Route: SKIN APPLICATION Time: 09:16:13 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 Page 1 NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 06/18/04 Route: SKIN APPLICATION Time: 09:16:13 ____________________________________________________________________________________________________________________________________ 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 (50%) Liver (15) (15) (15) (15) Hematopoietic Cell Proliferation 2 (13%) 2 (13%) 2 (13%) 3 (20%) Inflammation, Chronic Active 13 (87%) 12 (80%) 12 (80%) 12 (80%) Thrombosis 1 (7%) Hepatocyte, Degeneration 1 (7%) Hepatocyte, Fatty Change 1 (7%) Hepatocyte, Necrosis 1 (7%) 2 (13%) 1 (7%) 1 (7%) Hepatocyte, Vacuolization Cytoplasmic 3 (20%) 4 (27%) 3 (20%) 3 (20%) Salivary Glands (1) Atrophy 1 (100%) Inflammation, Chronic Active 1 (100%) Stomach, Forestomach (15) (15) (15) (15) Epithelium, Hyperkeratosis 1 (7%) 2 (13%) 1 (7%) 1 (7%) Epithelium, Hyperplasia 2 (13%) 2 (13%) 1 (7%) 2 (13%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (15) (15) (15) Accessory Adrenal Cortical Nodule 3 (20%) 3 (20%) 1 (7%) 1 (7%) Subcapsular, Hyperplasia 4 (27%) 3 (20%) 5 (33%) 3 (20%) Pituitary Gland (15) (15) (15) (15) Pars Distalis, Cyst 2 (13%) 1 (7%) 2 (13%) a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 06/18/04 Route: SKIN APPLICATION Time: 09:16:13 ____________________________________________________________________________________________________________________________________ TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 64 MG/KG 128 256 MG/KG MG/KG ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM - CONT Pars Intermedia, Cyst 1 (7%) Thyroid Gland (15) (15) (15) (15) Ectopic Thymus 1 (7%) Infiltration Cellular, Lymphocyte 6 (40%) 3 (20%) 12 (80%) Follicle, Cyst 1 (7%) 1 (7%) Follicle, Depletion Secretory 6 (40%) 11 (73%) 13 (87%) 14 (93%) Follicular Cell, Hypertrophy 1 (7%) 9 (60%) 12 (80%) 13 (87%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (15) (15) (15) (15) Atrophy 1 (7%) Cyst 1 (7%) 3 (20%) Hemorrhage 1 (7%) Pigmentation 1 (7%) Uterus (15) (15) (15) (15) Endometrium, Hyperplasia, Cystic 11 (73%) 9 (60%) 10 (67%) 10 (67%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node (2) (2) Mediastinal, Hyperplasia, Lymphoid 1 (50%) Lymph Node, Mandibular (15) (14) (14) (15) Hyperplasia, Lymphoid 4 (27%) 2 (14%) 2 (14%) 3 (20%) Lymph Node, Mesenteric (14) (14) (13) (15) Hyperplasia, Lymphoid 1 (7%) Spleen (15) (15) (15) (15) Atrophy 1 (7%) 1 (7%) 1 (7%) Hematopoietic Cell Proliferation 3 (20%) 5 (33%) 9 (60%) 10 (67%) Thymus (15) (14) (15) (15) Atrophy 1 (7%) 3 (21%) 4 (27%) 2 (13%) Cyst 2 (13%) 4 (29%) 2 (13%) 3 (20%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 06/18/04 Route: SKIN APPLICATION Time: 09:16:13 ____________________________________________________________________________________________________________________________________ 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 (7%) Inflammation, Chronic Active 1 (7%) 1 (7%) 1 (7%) Inflammation, Suppurative 1 (7%) Ulcer 1 (7%) Epidermis, Hyperplasia, Focal 2 (13%) 3 (20%) 3 (20%) 1 (7%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM Bone (1) Fracture 1 (100%) ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (15) (15) (15) (15) Inflammation, Chronic Active 2 (13%) Thrombosis 1 (7%) Alveolar Epithelium, Hyperplasia 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (15) (15) Nephropathy 8 (53%) 7 (47%) 13 (87%) 15 (100%) Renal Tubule, Dilatation 1 (7%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 06/18/04 Route: SKIN APPLICATION Time: 09:16:13 ____________________________________________________________________________________________________________________________________ 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 (7%) 1 (7%) Inflammation, Chronic Active 10 (67%) 6 (40%) 9 (60%) 11 (73%) Hepatocyte, Necrosis 1 (7%) 2 (13%) Hepatocyte, Vacuolization Cytoplasmic 6 (40%) 4 (27%) 3 (20%) 6 (40%) Mesentery (1) (1) Fat, Necrosis 1 (100%) 1 (100%) Stomach, Forestomach (15) (15) (15) (15) Epithelium, Hyperplasia 1 (7%) 2 (13%) 1 (7%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (15) (15) (15) (15) Accessory Adrenal Cortical Nodule 1 (7%) Hypertrophy 8 (53%) 4 (27%) 1 (7%) 3 (20%) Subcapsular, Hyperplasia 1 (7%) Pituitary Gland (15) (14) (15) (15) Pars Distalis, Cyst 3 (21%) 4 (27%) 3 (20%) Pars Distalis, Hyperplasia 1 (7%) Thyroid Gland (15) (15) (15) (15) Infiltration Cellular, Lymphocyte 1 (7%) Follicle, Depletion Secretory 7 (47%) 4 (27%) 5 (33%) 11 (73%) Follicular Cell, Hypertrophy 7 (47%) 10 (67%) 14 (93%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 06/18/04 Route: SKIN APPLICATION Time: 09:16:13 ____________________________________________________________________________________________________________________________________ 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 (7%) 2 (13%) Testes (15) (15) (15) (15) Cyst 1 (7%) 1 (7%) Germinal Epithelium, Degeneration 2 (13%) 2 (13%) 3 (20%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (15) (15) (15) (15) Necrosis, Lymphoid 1 (7%) 1 (7%) Lymph Node, Mesenteric (15) (15) (15) (15) Necrosis, Lymphoid 1 (7%) Spleen (15) (15) (15) (15) Atrophy 1 (7%) Hematopoietic Cell Proliferation 1 (7%) 2 (13%) Thymus (14) (15) (15) (15) Atrophy 1 (7%) 4 (27%) 1 (7%) 4 (27%) Cyst 2 (14%) 2 (13%) 2 (13%) 5 (33%) Ectopic Parathyroid Gland 1 (7%) Ectopic Thyroid 1 (7%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (15) (15) (15) (15) Hyperkeratosis 2 (13%) 3 (20%) 4 (27%) Hyperkeratosis, Focal 1 (7%) Inflammation, Chronic Active 1 (7%) Epidermis, Hyperplasia, Focal 3 (20%) 2 (13%) 3 (20%) 4 (27%) Site of Application - Epidermis, Hyperplasia, Focal 1 (7%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 97013-11 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: SUBCHRON 26-WEEK WATER DISINFECTION MODEL (SODIUM BROMATE) Date: 06/18/04 Route: SKIN APPLICATION Time: 09:16:13 ____________________________________________________________________________________________________________________________________ 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 (7%) Pigmentation 1 (7%) Thrombosis 1 (7%) Alveolar Epithelium, Hyperplasia 1 (7%) Alveolus, Infiltration Cellular, Histiocyte 1 (7%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (15) (15) (15) (15) Nephropathy 8 (53%) 8 (53%) 14 (93%) 14 (93%) Artery, Inflammation, Chronic Active 1 (7%) Renal Tubule, Dilatation 1 (7%) 2 (13%) Urethra (1) Bulbourethral Gland, Cyst 1 (100%) a Number of animals examined microscopically at site and number of animals with lesion Page 7 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------