PMID- 30268830 OWN - NLM STAT- MEDLINE DCOM- 20181211 LR - 20181211 IS - 1096-0295 (Electronic) IS - 0273-2300 (Linking) VI - 99 DP - 2018 Nov TI - Are skin sensitisation test methods relevant for proteins? PG - 244-248 LID - S0273-2300(18)30250-2 [pii] LID - 10.1016/j.yrtph.2018.09.028 [doi] AB - Tests for identification of chemical skin sensitisation hazard have been available for decades, evolving from guinea pig assays, through the first validated method, the local lymph node assay, to several validated in vitro methods. These methods successfully identify the hazard for chemicals, with an accuracy in the region of 85%. However, in some regulations, consideration may be given to their application to proteins. Here, the scientific relevance of the use of skin sensitisation tests for the assessment of the allergenic potential of proteins is reviewed and considered in the context of both: (a) what is known of the allergenic properties of proteins compared with chemicals, and (b) current understanding of the extent to which proteins actually give rise to contact allergy. There is no doubt that many foreign proteins can behave as respiratory sensitisers and food allergens, and that certain proteins can also cause cutaneous allergy via skin contact, typically mediated via immunoglobulin E (IgE) antibody. However, the absence of any specificity in predictions from existing skin sensitisation test methods, together with the lack of a suitable body of either positive or negative controls, dictates that use of these tests with proteins is without any scientific justification or predictive merit. CI - Copyright (c) 2018. Published by Elsevier Inc. FAU - Basketter, David A AU - Basketter DA AD - DABMEB Consultancy Ltd, Sharnbrook, MK44 1PR, UK. Electronic address: dabmebconsultancyltd@me.com. FAU - Kimber, Ian AU - Kimber I AD - Faculty of Biology, Medicine and Health, University of Manchester, Manchester, M13 9PT, UK. LA - eng PT - Journal Article PT - Review DEP - 20180927 PL - Netherlands TA - Regul Toxicol Pharmacol JT - Regulatory toxicology and pharmacology : RTP JID - 8214983 RN - 0 (Allergens) RN - 0 (Hazardous Substances) RN - 0 (Proteins) SB - IM MH - Allergens/immunology MH - Animals MH - Biological Assay/methods MH - Hazardous Substances/*immunology MH - Humans MH - Proteins/*immunology MH - Skin/*immunology MH - Skin Tests/*methods OTO - NOTNLM OT - Enzymes OT - Hazard identification OT - Proteins OT - Skin sensitisation EDAT- 2018/10/01 06:00 MHDA- 2018/12/12 06:00 CRDT- 2018/10/01 06:00 PHST- 2018/06/29 00:00 [received] PHST- 2018/09/24 00:00 [revised] PHST- 2018/09/26 00:00 [accepted] PHST- 2018/10/01 06:00 [pubmed] PHST- 2018/12/12 06:00 [medline] PHST- 2018/10/01 06:00 [entrez] AID - S0273-2300(18)30250-2 [pii] AID - 10.1016/j.yrtph.2018.09.028 [doi] PST - ppublish SO - Regul Toxicol Pharmacol. 2018 Nov;99:244-248. doi: 10.1016/j.yrtph.2018.09.028. Epub 2018 Sep 27.