Adaptation of the KeratinoSens™ skin sensitisation test to animal-product-free cell culture.

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Adaptation of the KeratinoSens™ skin sensitisation test to animal-product-free cell culture.

ALTEX. 2017 Mar 16;:

Authors: Belot N, Sim B, Longmore CL, Roscoe L, Treasure C

Abstract
Skin sensitisation is the process by which a substance leads to an allergic reaction following skin contact. The process has been described as an adverse outcome pathway (AOP), including several key events, from skin penetration and covalent protein binding, to keratinocyte activation, dendritic cell activation and T-lymphocyte proliferation. The in vitro assay KeratinoSens™ measures the activation of keratinocytes. It is fully accepted at a regulatory level (OECD TG 442d) and appropriate for compliance with a range of legislation including the EU Cosmetics Regulation, REACH, and the CLP Regulation. Currently, many in vitro methods use animal-derived components in the cell culture systems. Many stakeholders in the cosmetics industry have both scientific and ethical concerns relating to this issue and have stated a strong preference for fully human in vitro test systems. We have adapted the KeratinoSensTM method to animal product-free conditions, and carried out an in-house validation with 21 reference substances, including those listed in the Performance Standards associated with OECD TG442d. The modified method was shown to be totally equivalent to the Validated Reference Method (VRM), with comparable values for accuracy (85.7%), sensitivity (84.6%) and specificity (87.5%), and all acceptance criteria being met. In Europe, data generated by the adapted method may be used in REACH submissions, and we are now seeking approval to list the adaptation in OECD TG 442d, enabling formal compliance with a range of global regulations.

PMID: 28301666 [PubMed - as supplied by publisher]

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