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There are mounting public and legislative concerns about the use of animals in testing and the need to provide alternatives. At the same time, testing requirements are increasing under the new chemicals legislation (REACH). High expectations for alternative methods as well as societal, economical and ethical barriers are all major factors in this issue.
For the foreseeable future there are important aspects of safety assessment that will continue to require the use of experimental animals. Despite the aspiration of all stakeholders to reduce and where possible eliminate animal testing, the need for animals in ensuring continuing effective safety assessments should be understood and acknowledged.
A clear role for the chemical industry
• Cefic is a founding member and treasurer of the European Partnership for Alternative Approaches in Animal Testing (EPAA). Member companies are actively participating in the five EPAA Working Groups.
• Cefic is involved in the OECD Expert Group for New design for reproduction toxicity studies in mammals which evaluates the replacement of the standard 2-generational reprotox study (TG416) with a modular, enhanced 1-generational study protocol. The report from an LRI-sponsored literature analysis carried out at Cranfield University will form part of the scientific basis for the recommendations.
• Cefic is also represented in the OECD Validation Management Group (VMG) non-animal which deals with establishing in vitro test methods for endocrine disruptors.
• Early on LRI has been actively involved in the development and acceptance of chemoinformatic methods and QSAR tools. Workshops were sponsored and projects are being funded to develop cheminformatic data management tools.Results of these LRI projects have already been used by the European Chemicals Bureau (ECB) to build other tools (ToxTree, ToxMatch).
The AMBIT 2.0 Database - an LRI funded project - is a relational database with functional modules allowing a variety of evaluations, flexible structure, similarity searching and other queries.
AMBIT XT has delivered new scientific approaches to datamining based on chemical structure. Furthermore, these approaches are build into an open-source code web application which can host many different quality-assured datasets. Examples of publicly available datasets are the EINECS inventory with QA-ed structures and SMILES-codes, the "Gold Standard" BCF-dataset, LLNA dataset and many more phys-chem and toxicological endpoints (check the AMBIT website for more examples).
In a REACH context
Using AMBIT allows companies to maintain access to the European market at a reduced cost by leveraging existing knowledge. Substance specific data can be directly extracted from IUCLID into the PBT-assessment workflow in AMBIT. A new initiative we currently consider is to request SIEFs/Consrtia to share basic data on the critical study for a REACH-relevant endpoints and store these into one AMBIT dataset. This dataset can then be interrogated by other SIEFs to develop read-across strategies for their information gap filling. This initiative is intended to be complementary to the REACH data-sharing requirement within a SIEF/Consortia as it enhances the possibilities for data- and cost-sharing between SIEFs/Consortia."
Cefic has participated in the REACH Implementation Projects (RIPs) and ensured that the 3R principles are well integrated (RIP 3.3 on information requirements). Cefic is also promoting the use of Intelligent Testing Strategies (ITS) through the European technology platform for Sustainable Chemistry (SusChem).
For more information on Cefic's engagement in the 3R Principles of Toxicity Testing, click here.
You can also find here the press release of the EPAA Annual Conference that took place on November 6, in Brussels. The European Commission and major companies from seven sectors of European industry have agreed to continue collaborating in a partnership that aims at promoting alternative approaches to animal testing in regulation.