title: Toxicological assessment of the hemostatic system, regulatory requirements, and industry practice.
abstract: Disturbances of the hemostatic system which may be caused by chemicals include hemorrhagic diathesis, caused by inhibition of blood clotting, impairment of platelet function, and hyperactivity of fibrinolysis. Activation of the plasmatic clotting system, platelet aggregation, and inhibition of fibrinolysis may lead to thromboembolic complications. Although much is known about the functions of the hemostatic system a rational and cost-effective approach for its assessment in industrial toxicology is lacking. In this review the physiology of hemostasis and the available laboratory tests are discussed, current regulatory requirements are described, and industry practice is analyzed based on experience accumulated over the last 23 years. Proposals for a more flexible and scientific approach to testing of hemostatic mechanisms in toxicology are made.
mesh_terms: D000818:Animals; D001777:Blood Coagulation / Q000187:drug effects; D001780:Blood Coagulation Tests; D004345:Drug Industry / Q000592:standards; D005337:Fibrin / Q000502:physiology; D006077:Government Agencies; D006470:Hemorrhage / Q000139:chemically induced; D006487:Hemostasis / Q000187:drug effects*; D006801:Humans; D010979:Platelet Function Tests; D014116:Toxicology / Q000379:methods*; D014481:United States
chemical_list: D005337:Fibrin