title: Comparative analysis of toxicological evaluations for dermal exposure performed under two different EU regulatory frameworks.
abstract: Dermal exposure to chemicals is highly relevant in relation to the use of cosmetic products, both in consumers and in individuals exposed occupationally. Regulatory frameworks exist within the EU to limit the dermal exposure of the general population and workers to chemicals in general, as well as to limit the use of certain substances in cosmetic products. The objective of the study was to investigate and compare toxicological evaluations of dermal exposure performed under current regulatory frameworks. The publicly disseminated hazard information under the respective regulatory frameworks was compiled and compared for the five substances resorcinol, p-phenylenediamine, p-aminophenol, N-phenyl-p-phenylenediamine, and diethylene glycol monoethyl ether. A low consistency between evaluations was observed in respect to data coverage and cited dose descriptors. No systematic differences over all five substances were identified from the viewpoint of dermal hazard assessment. The critical effect and corresponding systemic effect dose descriptor was identical for two substances, differed somewhat for two other (a factor of 2-2.5). For N-phenyl-p-phenylenediamine a critical effect was only identified under REACH.
authors.affiliation: Department of Philosophy and History, Royal Institute of Technology, Teknikringen 78b, 100 44 Stockholm, Sweden.
authors.forename: Emma
authors.initials: E
authors.lastname: Westerholm
authors.affiliation: Department of Philosophy and History, Royal Institute of Technology, Teknikringen 78b, 100 44 Stockholm, Sweden; Institute of Environmental Medicine, Karolinska Institutet, Nobels väg 13, 171 77 Stockholm, Sweden. Electronic address: schenk@kth.se.
authors.forename: Linda
authors.initials: L
authors.lastname: Schenk
mesh_terms: D000279:Administration, Cutaneous; D000818:Animals; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D003358:Cosmetics / Q000633:toxicity*; D005062:European Union; D033161:Government Regulation; D015386:Hazardous Substances / Q000633:toxicity*; D006801:Humans; D019055:No-Observed-Adverse-Effect Level; D016273:Occupational Exposure; D018570:Risk Assessment / Q000331:legislation & jurisprudence; D012867:Skin; D018675:Toxicity Tests
chemical_list: D003358:Cosmetics; D015386:Hazardous Substances
keywords: Cosmetics regulation; DNEL; Derived no effect levels; ECHA; European Chemicals Agency; LD; LOAEL; MoS; NOAEL; REACH; Regulation; Risk management; SCCS; Scientific Committee on Consumer Safety; derived no effect level; lethal dose; lowest observed adverse effect level; margin of safety; no observed adverse effect level; registration, evaluation, authorization and restriction of chemicals