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Article related to: News from ECHA
Alternative methods to avoid testing on animals – an important new review
A new, state-of-the-art review of test methods and computational approaches has been produced for ECHA by the European Commission's Joint Research Centre (JRC). It promotes the replacement, reduction and refinement of animal experiments in the safety assessment of chemicals.
The report reviews the current scientific status of alternatives to animal experiments, such as in vitro test methods (for example, using cells or tissues) and computational models for several human health and ecotoxicological endpoints. It describes their availability and applicability based on knowledge of the underlying mechanisms of toxicology. The endpoints covered for human health range from skin and eye irritation to mutagenicity and carcinogenicity. In relation to the environment, the report focuses on methods for assessing acute and chronic fish toxicity.
Besides referring to REACH, CLP and the Biocidal Products Regulation, the report also informs about alternative methods in other sectors, such as cosmetics and plant protection products.
Better understanding of chemical properties
"This report was written by the JRC in close cooperation with ECHA's scientists. It gives a very useful overview of alternative methods and includes references and links for further reading for the academic and regulatory community," says Derek Knight, Senior Scientific Adviser at ECHA.
"This report is very timely. I think that there is a fundamental change in thinking in the regulatory community, due to a better understanding of the underlying biology behind how chemicals cause adverse effects to human health and the environment. The huge amount of data available from new techniques such as ‘omics' and high-throughput screening methods has an impact. The topical ideas are adverse outcome pathways (AOPs) and modes of action (MoA) as the underlying theory and integrated assessment and testing approaches (IATAs) as a means of combining multiple lines of evidence to give an overall prediction of a hazardous property for a chemical. The report has an excellent introductory chapter on AOPs to set the context for the detailed review for specific endpoints," Dr Knight explains.
According to Dr Knight, the report is a demonstration of ECHA and JRC's cooperation in which scientists' exchange leads to definite progress. The report was written at a time when consensus was emerging that an IATA could be devised for skin sensitisation. "The European Union Reference Laboratory for alternatives to animal testing is currently developing an IATA to meet the needs of REACH and CLP. The aim is to reduce the need for animal testing for the next registration deadline. IATAs will help registrants to use the existing information efficiently and to maximise the use of in vitro methods," he adds.
New in vitro tests for the 2018 deadline
Kimmo Louekari, Senior Scientific Officer at ECHA, highlights further areas in the report that are important for the next registration deadline. "On four endpoints, the progress of in vitro testing methods has been especially promising – skin sensitisation, skin corrosion, acute toxicity and eye irritation. These endpoints are relevant for registrants preparing their dossiers for the next registration deadline. With the new in vitro tests, many animal tests can be replaced especially on skin and eye irritation, and skin sensitisation," says Dr Louekari. He points out that, for example, skin sensitisation tests are based on adverse outcome pathways. "This implies that these tests, which are based on understanding the mechanisms of the toxic effect, are reliable and have high regulatory relevance," he adds.
ECHA is now also updating its guidance on information requirements with in vitro methods.
Scientific hub to promote alternative methods
One of ECHA's strategic aims for 2014-18 is to address scientific challenges by serving as a hub for scientific and regulatory capacity building. The Agency will bring together different actors to discuss scientific developments and cooperate closely with other organisations. To set strategic priorities for this work, ECHA is currently working on its regulatory science strategy. Capacity building for alternative testing methods and new tools play an important role in this work.
"This report can be seen as catalyst for our ideas on alternative methods. In particular, on how we can communicate research and development needs with the intention of steering work of practical use to REACH, CLP and Biocides. Other issues are already being followed up with the JRC and other scientific organisations. For example, work is ongoing regarding skin sensitisation and acute toxicity. Another promising idea focuses on the new fish embryo tests. In the medium-term, the idea is that these may replace acute toxicity tests currently done on fish," Dr Knight highlights.
- ECHA guidance on information requirements 7 CSR (to be updated in 2015-16)
- ECHA's page on testing methods and alternatives
- JRC report on the development, validation and regulatory acceptance of alternative methods/approaches
Interviews by Tiiu Bräutigam
Top image: ECHA
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Biocidal Products Committee:
26 February-1 March
Committee for Risk Assessment:
6-8 March and
Committee for Socio-Economic
Management Board meeting:
23-27 March (tentative)
Member State Committee:
20-24 April (tentative)