title: Science based guidance for the assessment of endocrine disrupting properties of chemicals.
abstract: The European legislation on plant protection products (Regulation (EC) No. 1107/2009) and biocides (Directive 98/8/EC), as well as the regulation concerning chemicals (Regulation (EC) No. 1907/2006 'REACH') only support the marketing and use of chemical products on the basis that they do not induce endocrine disruption in humans or non-target species. However, there is currently no agreed guidance on how to identify and evaluate endocrine activity and disruption. Consequently, an ECETOC task force was formed to provide scientific criteria that may be used within the context of these three legislative documents. Specific scientific criteria for the determination of endocrine disrupting properties that integrate information from both regulatory (eco)toxicity studies and mechanistic/screening studies are proposed. These criteria combine the nature of the adverse effects detected in studies which give concern for endocrine toxicity with an understanding of the mode of action of toxicity so that adverse effects can be explained scientifically. The criteria developed are presented in the form of flow charts for assessing relevant effects for both humans and wildlife species. In addition, since not all chemicals with endocrine disrupting properties are of equal hazard, assessment of potency is also proposed to discriminate chemicals of high concern from those of lower concern. The guidance presented in this paper includes refinements made to an initial proposal following discussion of the criteria at a workshop of invited regulatory, academic and industry scientists.
authors.affiliation: Bayer CropScience, 355 Rue Dostoïevsky, F-06903, Sophia Antipolis, France.
authors.forename: Remi
authors.initials: R
authors.lastname: Bars
authors.forename: Fabrice
authors.initials: F
authors.lastname: Broeckaert
authors.forename: Ivana
authors.initials: I
authors.lastname: Fegert
authors.forename: Melanie
authors.initials: M
authors.lastname: Gross
authors.forename: Nina
authors.initials: N
authors.lastname: Hallmark
authors.forename: Tim
authors.initials: T
authors.lastname: Kedwards
authors.forename: Dick
authors.initials: D
authors.lastname: Lewis
authors.forename: Sue
authors.initials: S
authors.lastname: O'Hagan
authors.forename: Grace H
authors.initials: GH
authors.lastname: Panter
authors.forename: Lennart
authors.initials: L
authors.lastname: Weltje
authors.forename: Arnd
authors.initials: A
authors.lastname: Weyers
authors.forename: James R
authors.initials: JR
authors.lastname: Wheeler
authors.forename: Malyka
authors.initials: M
authors.lastname: Galay-Burgos
mesh_terms: D026683:Advisory Committees; D000818:Animals; D054750:Ecotoxicology / Q000331:legislation & jurisprudence / Q000592:standards; D052244:Endocrine Disruptors / Q000633:toxicity*; D005060:Europe; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies; D018570:Risk Assessment; D018675:Toxicity Tests / Q000592:standards*; D014116:Toxicology / Q000331:legislation & jurisprudence / Q000592:standards*
chemical_list: D052244:Endocrine Disruptors