title: Consideration of criteria required for assignment of a (skin) sensitiser a substance of very high concern (SVHC) under the REACH regulation.
abstract: The identification, characterisation, risk assessment and risk management of materials that cause allergic sensitisation is an important requirement for human health protection. It has been proposed that for some chemical and protein allergens, and in particular for those that cause sensitisation of the respiratory tract (associated with occupational asthma), it may be appropriate to regard them as Substances of Very High Concern (SVHC) under the provisions of REACH (Registration, Evaluation, Authorisation and restriction of CHemicals). We have argued previously that categorisation of sensitising agents as SVHC should be used only in exceptional circumstances. In the present article, the subject of SVHC is addressed from another perspective. Here the information that would be required to provide a compelling case for categorisation of a skin sensitising substance as a SVHC is considered. Three skin sensitising chemicals have been identified to serve as working examples. These are chromate, a potent contact allergen, and the skin sensitisers formaldehyde and isoeugenol. The key criterion influencing the decision regarding a skin sensitiser being categorised as SVHC is the extent to which impacts on the quality of life are reversible. Consequently, SVHC categorisation for skin sensitising chemicals should be used only in exceptional circumstances.
authors.affiliation: DABMEB Consultancy Ltd., Sharnbrook, Bedfordshire MK44 1PR, UK. Electronic address: dabmebconsultancyltd@me.com.
authors.forename: David
authors.initials: D
authors.lastname: Basketter
authors.affiliation: Faculty of Life Sciences, University of Manchester, Manchester M13 9PT, UK.
authors.forename: Ian
authors.initials: I
authors.lastname: Kimber
mesh_terms: D000485:Allergens / Q000276:immunology*; D017449:Dermatitis, Allergic Contact / Q000209:etiology / Q000276:immunology; D006801:Humans; D011788:Quality of Life; D018570:Risk Assessment; D012867:Skin / Q000276:immunology*
chemical_list: D000485:Allergens
keywords: Hazard and risk categorisation; REACH; Respiratory sensitisers; SVHC; Sensitisation potency; Skin sensitisers; Substances of very high concern