ECVAM and OECD adopt Givaudan’s KeratinoSens® assay
For decades, the issue of animal testing on cosmetic products has proven an ethical dilemma for companies and consumers alike: whilst effective testing can ensure safety for products intended for human use, the practice of using sentient creatures for commercial gain has proved divisive and controversial.
In 2006, Givaudan began exploring alternatives to animal testing, which led to the development of the KeratinoSens® assay for skin sensitisation. KeratinoSens® is just one of a number of methodologies that replaces the need for testing on animals, and Givaudan made the decision to make this in-vitro assay openly available, working with the Organisation for Economic Co-operation and Development (OECD), to adopt and promote the solution.
Andreas is Senior Research Fellow Bioscience, Fragrance Research, at Givaudan, and the man responsible for developing KeratinoSens®. He brings us up to speed on developments in 2014: “In 2011, when we first published studies on the assay, we submitted KeratinoSens® to the European Centre for the Validation of Alternative Methods to animal testing (ECVAM). ECVAM validated KeratinoSens® along with two other methodologies, and proposed that these three methods may be used in an Integrated testing Strategy (ITS) for skin sensitisation to replace animal testing for regulatory purposes. KeratinoSens® finally received ECVAM approval in February 2014. This development led to a new OECD test guideline, which was adopted by the OECD one year later, on the 4 February 2015.”
What are the broader benefits of this development? Andreas continues: “Historically, the cosmetics industry has relied on animal testing, but in Europe, in 2013, new legislation was brought in effectively banning testing on animals. So this is an essential tool for cosmetics companies, many of whom Givaudan counts as customers, to have a proven solution in place. It also allows for earlier testing and more testing: so it doesn’t just replace former practices but actually speeds up the process, in a cost-effective way, which will, in turn, lead to safer products that can be brought to market quicker – something that consumers will benefit from, in every sense.”
Leading on from this point, Greg, Senior Vice President, Global Regulatory Affairs and Product Safety brings a further perspective to our achievements with KeratinoSens®: “Widespread adoption of KeratinoSens® will aid innovation, in so far as it allows for the high throughput screening of upstream technologies, enabling companies to design safety into their products. In 2014, Givaudan tested 300 molecules internally and we would never have been able to do this previously. This is sustainable innovation at its best.”
Opportunities within REACH
REACH is the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals. Amongst its aims, REACH ensures a high level of protection of human health and the environment from risks that can be posed by chemicals, and the promotion of alternative test methods. Greg points to the opportunities now open to companies, via the REACH programme: “If REACH were to adopt KeratinoSens® data that would certainly reduce the need for animal tests for sensitisation, for which there are many requirements. Hopefully, now that we have OECD acceptance, we can enter into discussions with the regulators to see if KeratinoSens® data will be broadly accepted within REACH.”
An outstanding achievement
Andreas received a personal accolade in 2014, when he was announced as one of the winners of the KGF-SCS Industrial Investigator Awards 2014, by the Swiss Chemical Society (SCS) and the Contact group for research matters (KGF): “It was a big honour for me, and I was delighted to accept the award, for myself, and on behalf of Givaudan, which has created a dynamic platform for research, enabling me to pursue my career goals.”
While KeratinoSens® has gained acceptance and adoption, another related area of research is now undergoing a similar process of evaluation: The trout S9 assay, which addresses the issue of bioaccumulation of chemicals in fish, as Andreas explains: “Bioaccumulation is critical in relation to fat-soluble molecules, and approaches currently relate to animal testing, requiring the use of fish, which is expensive and time-consuming. The S9 experiments allow for testing on just fish livers and we can test whether or not a molecule is eliminated by the liver, which indicates its bioaccumulative potential. The S9 assay was developed mainly by the US environmental protection agency, and in 2014, Givaudan was the first company to publish a study proving the use of the approach for fragrance molecules. As with KeratinoSens®, success in this area will streamline and speed up testing, making it more cost-effective, in line with the 3R principles, which are to Reduce, Refine and Replace animal testing. It is still early days, and we are collaborating with other parties, but we hope that our work on Bioaccumulation S9 will follow on from KeratinoSens®, in terms of validation and widespread adoption.”
Greg adds: “This is another area in which we are trying to find suitable alternatives where there is a prevailing need. Fish and aquatic organisms have not received the same focus as mammalian and human health with regards to animal testing, but it is important and we’re making good progress.”