Public Funding for Xcellr8 Limited

XCellR8 Limited aims to offer the first completely animal-free, _in vitro_ test for human acute oral toxicity prediction, combining a strong scientific rationale with the ethical advantages of a non-animal approach. In response to the critical need in the cosmetics sector for scientifically advanced, non-animal tests for acute toxicity, XCellR8 developed a Proof of Principle test to show that this could be achieved. Companies in the sector find themselves stuck between two contradictory regulations. XCellR8's test indicates that there is a way to resolve this gap and allow cosmetic companies to test new ingredients, not only to remove the need to test on animals but also to provide a more accurate test for human toxicity than traditional rodent models by utilising human-derived components. An EC-funded feasibility study confirmed that in order to unlock the full market potential of the test, the predictive capacity and sector applicability should be expanded, significantly enhancing the commercial opportunity. Ingredient suppliers in a range of industries -- notably industrial chemicals, biocides and agrochemicals, and medical devices - expressed an interest in the test, citing similar contradictory regulations in their own sectors. This Project will enable XCellR8 to develop a new, improved test with features that enhance its predictive capacity, and to ensure its applicability to a wider range of sectors, solidifying the commercial proposition. This will aid in establishing a UK-based SME, XCellR8, as a world leading company for the provision of non-animal technologies for the testing of human safety.

The EU ban on animal testing for cosmetics came into full effect on 11 March 2013 and was the culmination of several decades of campaigning with huge public support. This progress is now under threat by the EU REACH regulation, which still requires animal tests where there are no validated alternatives available. In addition, industry guidelines issued by other international organisations such as the Scientific Committee on Consumer Safety (SCCS) still advocate animal testing for the approval of new key ingredients such as preservatives and UV filters. This contradictory stance has resulted in a seemingly insurmountable barrier to gaining approval for new, innovative ingredients. These regulatory clashes present the UK / EU cosmetics industry with an enormous dilemma and places the future of the industry under significant threat, stifling innovation, as well as the supply of established ingredients. Non-animal replacement tests, which are both scientifically advanced and ethically sound, are urgently needed. The project will deliver several new and improved human-based in vitro and in vivo tests for cosmetic safety, circumventing the need for animal testing. The project partners will explore the feasibility of developing replacement tests for acute toxicity and repeat-dose toxicity that are scientifically relevant and sufficiently robust and reproducible for (ultimate) adoption as OECD Test Guidelines, in addition to improving a current non-regulatory test for mildness, for the purpose of claim support for innovative cosmetic ingredients.

The Cosmetics Regulation prohibits the testing of cosmetic products and their ingredients on animals, as well as the marketing of cosmetics and their ingredients that have been tested on animals for cosmetic purposes. The ban came into full effect on 11 March 2013 and was the culmination of several decades of campaigning with huge public support. This progress is now under threat by the EU REACH regulations, which still require certain animal tests to be performed. This regulatory clash presents the UK / EU cosmetics industry with an enormous dilemma and places the future of the industry under significant threat. Animal testing has long been a highly emotive issue in the cosmetics sector and a major market driver. REACH is broadly supportive of alternatives to animal testing, but still requires animal tests where there are currently no validated alternatives available. Non-animal replacement tests are urgently needed which are both scientifically advanced and ethically sound. The project partners will explore the feasibility of developing relacement tests for acute toxicity that are scientifically relevant and sufficiently robust and reproducible for (ultimate) adoption as OECD Test Guidelines.