TDMS Study 97013-97 Pathology Tables
NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 11/04/03 Route: GAVAGE Time: 12:00:46 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 Page 1 NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 11/04/03 Route: GAVAGE Time: 12:00:46 ____________________________________________________________________________________________________________________________________ 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 (100%) Intestine Large, Colon (10) (10) (10) (10) Inflammation 1 (10%) Intestine Large, Cecum (10) (10) (10) (10) Edema 1 (10%) Inflammation 1 (10%) Intestine Small, Ileum (10) (10) (10) (10) Ulcer 1 (10%) Liver (10) (10) (10) (10) Cytomegaly 1 (10%) Hematopoietic Cell Proliferation 1 (10%) 2 (20%) 3 (30%) Inflammation 8 (80%) 9 (90%) 10 (100%) 6 (60%) Necrosis 2 (20%) 2 (20%) 1 (10%) 1 (10%) Hepatocyte, Fatty Change 2 (20%) 8 (80%) 5 (50%) Hepatocyte, Vacuolization Cytoplasmic 6 (60%) 9 (90%) 10 (100%) 9 (90%) Mesentery (1) Hemorrhage 1 (100%) Artery, Inflammation 1 (100%) Artery, Thrombosis 1 (100%) Stomach, Forestomach (10) (10) (10) (10) Hyperkeratosis 1 (10%) 2 (20%) 4 (40%) 4 (40%) Epithelium, Hyperplasia 1 (10%) 2 (20%) 4 (40%) 4 (40%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 2 NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 11/04/03 Route: GAVAGE Time: 12:00:46 ____________________________________________________________________________________________________________________________________ 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 (10%) 1 (10%) Subcapsular, Hyperplasia 5 (50%) 6 (60%) 4 (40%) 7 (70%) Islets, Pancreatic (1) Hyperplasia 1 (100%) Pituitary Gland (10) (10) (10) (10) Cyst 2 (20%) 1 (10%) 1 (10%) Thyroid Gland (10) (10) (10) (10) Cyst 2 (20%) 5 (50%) 2 (20%) 2 (20%) ____________________________________________________________________________________________________________________________________ GENERAL BODY SYSTEM None ____________________________________________________________________________________________________________________________________ GENITAL SYSTEM Ovary (10) (10) (10) (10) Amyloid Deposition 1 (10%) Atrophy 1 (10%) Cyst 1 (10%) 3 (30%) 1 (10%) Inflammation, Suppurative 1 (10%) Oviduct (1) Inflammation, Suppurative 1 (100%) Uterus (10) (10) (10) (10) Inflammation 1 (10%) 1 (10%) Inflammation, Granulomatous 1 (10%) Endometrium, Hyperplasia, Cystic 7 (70%) 10 (100%) 9 (90%) 8 (80%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (10) (10) (10) (9) Hyperplasia 1 (10%) Infiltration Cellular, Plasma Cell 2 (20%) 1 (10%) 2 (22%) Lymph Node, Mesenteric (10) (10) (10) (10) Atrophy 1 (10%) 1 (10%) Ectasia 1 (10%) Spleen (10) (10) (10) (10) Atrophy 2 (20%) 1 (10%) Hematopoietic Cell Proliferation 1 (10%) 2 (20%) 5 (50%) a Number of animals examined microscopically at site and number of animals with lesion Page 3 NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 11/04/03 Route: GAVAGE Time: 12:00:46 ____________________________________________________________________________________________________________________________________ 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 (20%) 1 (10%) 4 (44%) Cyst 3 (30%) 2 (20%) 5 (50%) 3 (33%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Mammary Gland (1) Inflammation, Granulomatous 1 (100%) Skin (6) (5) (7) (7) Hyperplasia 1 (17%) 3 (60%) 2 (29%) Epidermis, Hyperplasia, Focal 1 (20%) 1 (14%) Subcutaneous Tissue, Hemorrhage 1 (14%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM None ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (10) (10) (10) (10) Inflammation 1 (10%) Perivascular, Inflammation 2 (20%) 1 (10%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) (10) Amyloid Deposition 1 (10%) Casts Protein 1 (10%) 2 (20%) 6 (60%) Cyst 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 4 NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 11/04/03 Route: GAVAGE Time: 12:00:46 ____________________________________________________________________________________________________________________________________ TGAC (FVB/N) HEMIZYGOUS FEMALE 0 MG/KG 25 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ URINARY SYSTEM - CONT Infiltration Cellular, Lymphocyte 1 (10%) Nephropathy 3 (30%) 4 (40%) 5 (50%) Renal Tubule, Hypertrophy 1 (10%) a Number of animals examined microscopically at site and number of animals with lesion Page 5 NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 11/04/03 Route: GAVAGE Time: 12:00:46 ____________________________________________________________________________________________________________________________________ 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 (20%) 1 (10%) 1 (10%) Inflammation 7 (70%) 6 (60%) 8 (80%) 5 (50%) Necrosis 2 (20%) Hepatocyte, Fatty Change 2 (20%) Hepatocyte, Vacuolization Cytoplasmic 6 (60%) 3 (30%) 7 (70%) 7 (70%) Hepatocyte, Vacuolization Cytoplasmic, Diffuse 2 (20%) Stomach, Forestomach (10) (10) (10) (10) Hyperkeratosis 2 (20%) 3 (30%) 2 (20%) Epithelium, Hyperplasia 2 (20%) 3 (30%) 2 (20%) ____________________________________________________________________________________________________________________________________ CARDIOVASCULAR SYSTEM None ____________________________________________________________________________________________________________________________________ ENDOCRINE SYSTEM Adrenal Cortex (10) (10) (10) (10) Hypertrophy 7 (70%) 3 (30%) 6 (60%) 7 (70%) Subcapsular, Hyperplasia 1 (10%) 2 (20%) Pituitary Gland (10) (10) (10) (10) Cyst 1 (10%) 1 (10%) 1 (10%) Thyroid Gland (10) (10) (10) (10) Cyst 2 (20%) 1 (10%) 1 (10%) ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 6 NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 11/04/03 Route: GAVAGE Time: 12:00:46 ____________________________________________________________________________________________________________________________________ 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 (10%) 1 (10%) Preputial Gland (1) Inflammation, Suppurative 1 (100%) Testes (10) (10) (10) (10) Germinal Epithelium, Degeneration 2 (20%) 1 (10%) 1 (10%) ____________________________________________________________________________________________________________________________________ HEMATOPOIETIC SYSTEM Lymph Node, Mandibular (10) (9) (9) (10) Hematopoietic Cell Proliferation 1 (10%) Hyperplasia 1 (10%) 1 (11%) 1 (11%) 1 (10%) Infiltration Cellular, Plasma Cell 1 (10%) 2 (22%) 1 (10%) Lymph Node, Mesenteric (10) (10) (10) (10) Hyperplasia 1 (10%) Spleen (10) (10) (10) (10) Atrophy 1 (10%) Hematopoietic Cell Proliferation 4 (40%) 2 (20%) 1 (10%) Thymus (9) (10) (10) (10) Atrophy 3 (33%) 3 (30%) 3 (30%) 2 (20%) Cyst 4 (44%) 2 (20%) 2 (20%) 3 (30%) ____________________________________________________________________________________________________________________________________ INTEGUMENTARY SYSTEM Skin (5) (6) (5) (7) Hyperplasia 1 (17%) 2 (40%) 4 (57%) Inflammation 1 (14%) Subcutaneous Tissue, Fibrosis 1 (14%) ____________________________________________________________________________________________________________________________________ MUSCULOSKELETAL SYSTEM None ____________________________________________________________________________________________________________________________________ a Number of animals examined microscopically at site and number of animals with lesion Page 7 NTP Experiment-Test: 97013-97 INCIDENCE RATES OF NONNEOPLASTIC LESIONS BY ANATOMIC SITE (a) Report: PEIRPT03 Study Type: 26-39 WEEKS WATER DISINFECTION MODEL (BROMODICHLOROMETHANE) Date: 11/04/03 Route: GAVAGE Time: 12:00:46 ____________________________________________________________________________________________________________________________________ TGAC (FVB/N) HEMIZYGOUS MALE 0 MG/KG 25 MG/KG 50 MG/KG 100 MG/KG ____________________________________________________________________________________________________________________________________ NERVOUS SYSTEM Peripheral Nerve (1) Degeneration 1 (100%) ____________________________________________________________________________________________________________________________________ RESPIRATORY SYSTEM Lung (10) (10) (10) (10) Inflammation 1 (10%) 1 (10%) 2 (20%) Alveolar Epithelium, Hyperplasia 1 (10%) Perivascular, Inflammation 1 (10%) 1 (10%) Pleura (3) Inflammation, Suppurative 3 (100%) ____________________________________________________________________________________________________________________________________ SPECIAL SENSES SYSTEM None ____________________________________________________________________________________________________________________________________ URINARY SYSTEM Kidney (10) (10) (10) (10) Casts Protein 3 (30%) 1 (10%) 1 (10%) Cyst 1 (10%) 2 (20%) Nephropathy 3 (30%) 4 (40%) 6 (60%) 6 (60%) Glomerulus, Inflammation, Membranoproliferative 1 (10%) Renal Tubule, Degeneration 6 (60%) Renal Tubule, Dilatation 2 (20%) 2 (20%) 4 (40%) a Number of animals examined microscopically at site and number of animals with lesion Page 8 ------------------------------------------------------------ ---------- END OF REPORT ---------- ------------------------------------------------------------