title: Incorporating mechanistic data into risk assessment.
abstract: Incorporating mechanistic data into risk assessment is intended to improve the overall scientific validity, and thereby reduce the uncertainty, in human risk analysis. Relevant mechanistic data provides a link between the molecular and cellular event(s) and adverse outcome, and insight into mechanism of action is critical for accurate evaluation of dose-response relationships and inter-species extrapolation. This paper provides an example of applying mechanistic data to human risk assessment using the frameworks outlined by the International Programme on Chemical Safety (IPCS) and the U.S. Environmental Protection Agency (USEPA). Key components of the data are used to address the strength and consistency of the mechanism and to apply these data to human risk characterization.
authors.affiliation: Human Safety Department, Procter and Gamble Co., Cincinnati, OH, USA. lois.lehman-mckeeman@bms.com
authors.forename: Lois D
authors.initials: LD
authors.lastname: Lehman-McKeeman
mesh_terms: D000818:Animals; D016466:CHO Cells; D015197:Carcinogenicity Tests; D002273:Carcinogens / Q000633:toxicity; D002796:Choline Deficiency / Q000473:pathology; D006224:Cricetinae; D004983:Ethanolamines / Q000633:toxicity; D006801:Humans; D051379:Mice; D051381:Rats; D018570:Risk Assessment / Q000706:statistics & numerical data*; D012436:S-Adenosylmethionine / Q000494:pharmacology
chemical_list: D002273:Carcinogens; D004983:Ethanolamines; D012436:S-Adenosylmethionine; C020283:diethanolamine