A.I.S.E. is delighted to see the official publication by OECD of the revised version of Test Guideline No. 438 that can be used to classify products (e.g. detergents and surfactants) as ‘causing serious eye damage’. Using the outcome of its in vitro eye irritation programme that began in 2010, A.I.S.E. – with the support of the Netherlands – initiated in 2014 the process of official adoption for this revised OECD Test Guideline. A.I.S.E. hopes that this milestone contributes to the further acceptance of in vitro data in the classification and labelling of detergents and cleaning products.
The UN Globally Harmonised Sytem for Classification and labelling of products is implemented in Europe through the CLP regulation. The aim of the regulation is that consumers and workers should be provided with relevant and adequate information that allows them to recognise the real hazard of a product and get relevant safe use guidance. Industry has different options to classify their products (with regard to their potential impact on man and/or the environment) and ultimately label them accordingly. Making use of data on the product itself (e.g. via test) or bridging with existing data on similar mixtures is one of the preferred methodologies, enabling thus a more meaningful and pertinent labelling (versus the default additivity approach based on ingredient classification). In that framework, the ability to use relevant data (both in vitro and historical in vivo) on many tested mixtures is key. The revised Test now includes the possibility to use histopathology as an additional endpoint to the Isolated Chicken Eye Test Method in order to identify non-extreme pH detergents and surfactants that require UN GHS Category 1 classification. As such, the availability of the newly adopted revised OECD Test Guideline no. 438 is a major step forward for integration of robust and most effective in vitro test methods into this framework.
“We warmly welcome the in vitro Test Method that A.I.S.E. has succeeded to realise. We applaud industries who are trying their very best to develop non-animal tests. The objective of the Netherlands is to accelerate the transition from working with animal testing to working with non-animal tests. The Netherlands are doing this via the ‘Transition Programme for Innovation without the use of animals’. It would be great if the example set by A.I.S.E. would be followed by many other industrial partners” said a representative from the Dutch Authorities.
This Test well complements the activities of the European Partnership for Alternative Approaches to Animal Testing (EPAA) for which A.I.S.E. is a founding member.
Susanne Zänker, A.I.S.E. Director General, concluded: “We are delighted to see industry’s efforts rewarded by this publication. The close involvement that our experts have had with Authorities and scientists on this demonstrates the value of collaborative partnerships. We hope that this achievement will enable to further establish the broader acceptance of in-vitro tests under CLP and A.I.S.E. will continue to work with Authorities at national, European and global levels to this end”.
