Abstract
Skin sensitisation is the regulatory endpoint that has been at the centre of concerted efforts to replace animal testing in recent years, as demonstrated by the Organisation for Economic Co-operation and Development (OECD) adoption of five non-animal methods addressing mechanisms under the first three key events of the skin sensitisation adverse outcome pathway. Nevertheless, the currently adopted methods, when used in isolation, are not sufficient to fulfil regulatory requirements on the skin sensitisation potential and potency of chemicals comparable to that provided by the regulatory animal tests. For this reason, a number of defined approaches integrating data from these methods with other relevant information have been proposed and documented by the OECD. With the aim to further enhance regulatory consideration and adoption of defined approaches, the European Union Reference Laboratory for Alternatives to Animal testing in collaboration with the International Cooperation on Alternative Test Methods hosted, on 4–5 October 2016, a workshop on the international regulatory applicability and acceptance of alternative non-animal approaches, i.e., defined approaches, to skin sensitisation assessment of chemicals used in a variety of sectors. The workshop convened representatives from more than 20 regulatory authorities from the European Union, United States, Canada, Japan, South Korea, Brazil and China. There was a general consensus among the workshop participants that to maximise global regulatory acceptance of data generated with defined approaches, international harmonisation and standardisation are needed. Potential assessment criteria were defined for a systematic evaluation of existing defined approaches that would facilitate their translation into international standards, e.g., into a performance-based Test Guideline. Informed by the discussions at the workshop, the ICATM members propose practical ways to further promote the regulatory use and facilitate adoption of defined approaches for skin sensitisation assessments.
Highlights
Skin sensitisation is a regulatory endpoint required for many chemical sectors and has been at the centre of concerted efforts to replace animal testing in recent years
The currently adopted test methods, when used in isolation, are not able to fulfil all regulatory requirements on the skin sensitisation potential and potency of chemicals comparable to that provided by the regulatory animal tests, i.e., the Local Lymph Node Assay (LLNA) (OECD Test Guidelines (TG) 429) (OECD 2010a) or its non-radioactive variants, LLNA: defined approaches (DAs) (OECD TG 442A) (OECD 2010b) and LLNA: BrdU-ELISA (OECD TG 442B) (OECD 2010c), and the Guinea Pig Maximisation Test (GPMT) and Buehler Test (OECD 1992)
Considerable progress has been made in the area of non-animal methods for skin sensitisation assessment
Summary
Skin sensitisation is a regulatory endpoint required for many chemical sectors (e.g., industrial chemicals, pesticides, and cosmetics) and has been at the centre of concerted efforts to replace animal testing in recent years. The workshop convened representatives from more than 20 regulatory authorities from the European Union (EU), United States (US), Canada, Japan South Korea, Brazil, and China, to facilitate a common understanding of the available non-animal methods (i.e., in vitro, in chemico, in silico and read-across) and their role within DAs. Working together to identify potential obstacles, the international and crosssector group defined a series of steps that should be taken to support the regulatory application of DAs. The participants initially focused on the current regulatory requirements for skin sensitisation in different regions by chemical sector (i.e., pesticides, cosmetics, pharmaceuticals, industrial chemicals, etc.). ICATM partners agreed that the ultimate common goal among countries and agencies is the international harmonisation of regulatory requirements that would allow the use of DAs instead of the current regulatory animal tests To achieve this goal, work is ongoing with the OECD to develop an evaluation framework for DAs for skin sensitisation. Multi-stakeholder dialogues and international collaborations to share knowledge and experience will increase confidence and facilitate the widespread implementation and regulatory use of non-animal approaches
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