Community Research and Development Information Service - CORDIS


AFTAT Report Summary

Project ID: 728993

Periodic Reporting for period 1 - AFTAT (“Animal-Free Testing for Acute Toxicity”)

Reporting period: 2016-07-01 to 2016-12-31

Summary of the context and overall objectives of the project

XCellR8 Limited aims to offer the first completely animal-free test for human acute toxicity. The primary focus was for cosmetic product safety but the test will now be applied to other industry sectors including industrial chemicals, biocides and plant protection products. In this context, animal-free means in vitro human cell culture based methods that do not utilise any animal-derived components. Previous attempts to develop such tests used mouse cells and animal-derived components in the culture system and therefore still ultimately required the sacrifice of animals – an approach that is not considered acceptable by many companies and by a majority of the public.

The technological feasibility of the project has already been established, through existing tests of XCellR8’s internally developed proprietary methods. This feasibility assessment project was primarily required to address other practical, commercial, regulatory and financial aspects. It also expanded existing market research to assess the appetite of a greater cross-section of industry for such tests. During the project XCellR8 investigated the alternative routes for test development and adoption by industry as a non-regulatory test to support product development.

The ultimate objective is the international validation of the test and regulatory acceptance via incorporation into OECD Guidelines as part of a tiered testing strategy for human acute toxicity. The proposed project constitutes scientific advancement, using a fully human based method to assess human safety, as well as providing ethical, financial and commercial advantages over the use of animal tests. This offers a true innovation, with an SME creating a pioneering solution that could bring a fundamental change to the manner in which companies (and their suppliers) validate the safety of the raw materials used in their products.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

This Project has enabled XCellR8 to:

1). Expand existing market research to assess the appetite of a greater cross-section of industry for such tests. Focus on cosmetic companies and supply chain, but also expand out to some other industries to get a preliminary view of wider applicability. Stakeholder feedback gained during the project indicated that there would be a significant opportunity to apply the technology in the household products sector as well as the wider industrial chemicals field.
Expand upon existing market research to assess the appetite of a wider range of sectors for the technology, it was determined that there may be an opportunity to apply the technology in the household products sector.

2). Explore the best route for further development of the test: development activities to investigate expanding the applicability of the tests (e.g. from single substances to mixtures; from the cosmetics industry to other industry sectors) as an alternative option to full validation. The applicability domain was discussed with stakeholders. As with existing approved tests, it was determined that a sensible approach would be to seek regulatory acceptance of the standard test for single substances for a number of industry sectors (as above), with follow up research planned into its applicability to mixtures.

3). Develop a regulatory road map to clearly define the timelines of each stage required to achieve eventual regulatory status for the test. Regulatory experts and organisations have been consulted.

4). Develop a financial plan, clearly defining the costs involved to implement the regulatory roadmap and other development activities. Various stakeholders and experts have been consulted to gather the necessary information.

5). Assess the economic viability of the various parts of the overall project, and assess the anticipated commercial gain for XCellR8 (revenue, profit, jobs created). Time has been devoted to a detailed commercial assessment.

6). Assess any competing technologies as well as complementary technologies which may be employed to create an eventual tiered testing strategy for acute toxicity, enhancing the longterm value to various industry sectors.

7). Identify priorities based on practical and financial aspects and create a timeline and budget for further development. Analyse current capacity along with additional resources required to execute the business plan.

8). Establish a detailed business plan including Critical Path Analysis.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The societal implications for the Project are significant, as this Project has the potential to completely eradicate the need for the testing of cosmetics on animals. It is clear that much of the European population is against the unnecessary use of animals for cosmetic testing purposes. An opinion poll carried out in 2009 by leading polling company YouGov in the UK, France, Germany, Italy, Sweden and the Czech Republic found strong public support (79%) against animal research not relating to serious or life-threatening human conditions. A 2014 paper from Ipsos Mori ‘Public Attitudes to the Use of Animals in Scientific Research in 2014’ demonstrated that as much as 95% of the UK population are against the use of animals in the testing of cosmetics.

The main economic benefits for users of the technology are:

• Cost and time savings due to the growth and maintenance of cell lines rather than the costs of breeding, caring for and disposing of live animals required for the standard LD50 and related animal tests.
• It will unlock the associated marketing potential of a pro-active approach to testing. Many companies already claim that their products are ‘not tested on animals’, however, this can often mean that they are not proactively testing at all. The availability of new and innovative methods will allow these companies to proactively state that new products were ‘tested using advanced animal-free alternatives. To a clear commercial advantage in an age of ethically aware consumers.

Prior to the Project there were no known direct competitors in terms of adapting existing in vitro methods to animal-free conditions. Scrutiny and analysis of the market during the Project has shown that demand continues but there are still no adequate competing solutions in development.

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