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FS07.3
Skin sensitisation thresholds: a legislative perspective
Author(s) -
Basketter David
Publication year - 2004
Publication title -
contact dermatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.524
H-Index - 96
eISSN - 1600-0536
pISSN - 0105-1873
DOI - 10.1111/j.0105-1873.2004.0309bs.x
Subject(s) - local lymph node assay , legislation , cosmetics , allergic contact dermatitis , risk analysis (engineering) , medicine , potency , environmental health , business , toxicology , immunology , skin sensitization , political science , pathology , biology , allergy , biochemistry , sensitization , law , in vitro
Current EU legislation for skin sensitisers is a simple device, which crudely distinguishes between chemicals which possess significant sensitising potential and those which do not. Where a chemical is clearly positive in predictive tests or by human experience, it is classified and labelled R43: May cause sensitisation by skin contact. Use of such a chemical at ?1% in products would require appropriate labelling. Additional labelling requirements in relation to elicitation also exist, or are planned, which variously impact cosmetics, detergents and a wide range of other consumer products. Improvements to this basic system are presently under consideration and largely are focused on a consideration of options to categorise sensitising chemicals according to their potency. Central to this activity has been the demonstration of the utility of the local lymph node assay (LLNA) as a predictor of the human potency of skin sensitisers. Arising from this, both industry (ECETOC) and regulatory bodies in the EU have taken proactive steps to initiate improvement in the existing legislation. However, at a wider regulatory level, the debate currently centres on whether formal validation processes are required to progress potency categorisation at the OECD level, and if so how many categories and with what threshold levels. Political niceties here represent a barrier to progressing improvements in human health protection.