Guidance Document on the Reporting of Defined Approaches and Individual Information Sources to be Used within Integrated Approaches to Testing and Assessment (IATA) for Skin Sensitisation

Abstract

This publication was developed in the IOMC context. The contents do not necessarily reflect the views or stated policies of individual IOMC Participating Organisations. The Inter-Organisation Programme for the Sound Management of Chemicals (IOMC) was established in 1995 following recommendations made by the 1992 UN Conference on Environment and Development to strengthen co-operation and increase international co-ordination in the field of chemical safety. The Participating Organisations are FAO, ILO, UNDP, UNEP, UNIDO, UNITAR, WHO, World Bank and OECD. The purpose of the IOMC is to promote co-ordination of the policies and activities pursued by the Participating Organisations, jointly or separately, to achieve the sound management of chemicals in relation to human health and the environment. ENV/JM/MONO(2016)29 5 This publication is available electronically, at no charge. For this and many other Environment, Health and Safety publications, consult the OECD's World Wide Web site (www.oecd.org/chemicalsafety/)

Sensitization potential of medical devices detected by in vitro and in vivo methods

“…Since the first publication of the adverse outcome pathway for skin sensitization in vitro in 2012 (OECD, 2012), efforts have been made to develop an Integrated Approach to Testing and Assessment (IATA) for skin sensitization. This approach of toxicity testing, hazard and risk assessment integrates various types of chemical and toxicological data into the decision-making process (OECD, 2014;OECD, 2017).…”

“…Skin sensitization is a comprehensive immune response, therefore, alternative methods that assess a single key event alone are considered insufficient for evaluating the ability of a test substance to induce skin sensitization. Thus, focus has been increasingly laid on complex assessment that combines at least two in chemico or in vitro methods (addressing different key events), resulting in the "2 out of 3 approach" (OECD, 2017;Bauch et al, 2012). A single test may be performed for each of the key events 1, 2 and 3 (peptide/protein binding, keratinocyte activation, and dendritic cell activation), respectively.…”

“…A study published by Otsubo et al, 2017, suggested that a binary test battery of KeratinoSens TM and h-CLAT could be useful as part of a bottom-up approach, where the testing strategy suggests using test methods that can reliably define non-sensitizers (Scott et al, 2010). An international endeavour has been made to find a defined approach (DA) consisting of an established data interpretation procedure applied to results, generated with a defined collection of information sources to derive a prediction of skin sensitization (OECD, 2017).…”

Performance of a novel in vitro assay for skin sensitization based on activation of T lymphocytes

“…The Jurkat Clone E6-1 human T lymphocyte is an immortal cell line often used in studies on in vitro human T cell activation (Fernández-Riejos et al, 2008;Pan et al, 2015;Ngo et al, 2017;Chen et al, 2018;Vis et al, 2018;Colin-York et al, 2019;Kim et al, 2019). It has been reported that for some chemicals that incubating them in vitro with the Jurkat T cells in culture medium induced early T cell activation manifesting as an increase in CD69 expression on the Jurkat T cells in the absence of APCs in the test system (Fernández-Riejos et al, 2008;Chen et al, 2018;Vis et al, 2018).…”

“…(2) The protein-hapten (chemical) complexes may bind the T cell antigen receptors (TCRs) on the Jurkat T cells directly in this in vitro condition without the aid of APCs. (3) Like a naïve T cell, the Jurkat Clone E6-1 human T cell line expresses CD3 and TCRs and is commonly used in in vitro studies on human T cell activation (Fernández-Riejos et al, 2008;Pan et al, 2015;Ngo et al, 2017;Chen et al, 2018;Vis et al, 2018;Colin-York et al, 2019;Kim et al, 2019). ( 4) It ap-model, CD69 expression on the T cells indeed was induced by most of the sensitizers.…”