ECHA

ECHA has published its second report on the use of alternatives to animal testing under REACH. The Director for Evaluation, Leena Ylä-Mononen, highlights the main findings of the report.

Have registrants advanced in the use of alternative methods? Where do you see the most progress made?

Our report shows that registrants have made extensive use of the different possibilities outlined in REACH to avoid unnecessary animal testing. Over 38 000 dossiers were the main source of information for this report. The most frequently used alternative approach was read-across, which involves filling a data gap by using information on similar substances. This was used in more than 70 % of the analysed dossiers for at least one endpoint. The most progress was made regarding the use of in vitro studies, which use cells, tissues or organs. Registrants used them to test skin corrosion, skin irritation and eye irritation. Almost 20 % of the analysed dossiers contained in vitro studies for these endpoints.

Concerning toxicity towards the environment, (Q)SARs have increasingly been used for bioaccumulation in fish. This means computer modelling to estimate properties of a chemical from its molecular structure.

However, this is a numerical report and does not address the quality of how the alternatives were used. We will address the quality issue in our dossier evaluation decisions and in next year's evaluation report, as usual.

Leena Ylä-Mononen, Director for Evaluation.

What are ECHA's priorities for promoting alternative methods?

We want to direct research towards the development of alternative test methods. A number of actions in our Multi-Annual Work Programme 2014-2018 aim to support the development of scientifically-sound alternatives. For example, we will establish a framework for read-across assessment and improve the assessment of skin sensitisation.

Currently, we have prioritised those alternative methods that are developed well enough to be usedfor regulatory purposes. As an example, we published illustrative examples on the use of read-across and (Q)SARs. We are planning to publish more examples of this kind.

Our website contains a recently launched section called 'Testing methods and alternatives', having a page on the OECD and EU test guidelines. It refers to recent developments in the test guidelines, e.g. in vitro methods concerning skin and eye irritation, and how registrants can use these test methods.

There are new promising techniques for assessing skin sensitisation using in vitro methods, computer simulation or chemical reactivity methods. Together with the Commission's Joint Research Centre, ECHA is currently assessing how these new methods could be used to fulfil the REACH information requirement for an in vivo skin sensitisation study. The aim is to publish guidance ahead of the 2018 deadline.

Which alternative methods are especially relevant for the 2018 deadline? How is ECHA supporting registrants?

Regarding the registrations for 2018, read-across will be an important alternative approach to assess systemic toxicity endpoints. For registrations above 10 tonnes, REACH requires a 28-day study on repeated toxicity, and there are no suitable in vitro methods for this, so far.

For new and existing registrants, we offer an important source of information on existing alternative methods in practice – our dossier evaluation decisions. In December 2012, we started publishing non-confidential versions of all dossier evaluation decisions on our website. This gives registrants and third parties an opportunity to follow the outcome of compliance checks and testing proposal examinations and learn from them. For example, the decisions on testing proposals for the different categories and read-across give good insight into how these have been used by previous registrants. Registrants who recently submitted or are still preparing their dossiers can still use the opportunity and review their data. If they learn important lessons by reviewing the published decisions, they can proactively update their dossiers.

We also strive to prevent unnecessary animal testing in our recommendations and the advice we offer through webinars, guidance updates, practical guides and targeted events for registrants.

Can alternative methods entirely replace testing on animals in the future?

Unfortunately, not in the near future. There are still areas where scientifically reliable results are not yet available using alternative methods. If we talk about in vitro test methods – whether used alone or in combination with other techniques – we are still far away from replacing all animal tests. It is difficult to mimic a living organism especially when looking at systemic toxicity, for example, after repeated exposure or developmental toxicity. Read-across is the method that shows the most promise. However, even this approach may sometimes need to be supported with animal studies, for example, on toxicokinetics.

ECHA contributes to the EU's SEURAT1-project, promoting the use of read-across with a focus on repeated dose toxicity. The aim is to integrate the latest scientific developments with current regulatory practice.

The development of alternative methods is an important issue for many stakeholders and policy makers at EU level. We hope that our report supports the Commission in communicating about these alternatives and in considering further research initiatives and policy developments in this area.

Futher information:

Report and summary

OECD test guidelines page

Practical guides

Text by Tiiu Bräutigam

Top image: Fotolia