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.
