XCellR8’s GLP-accredited laboratory provides the first truly animal-free preliminary screen for human acute oral toxicity.
Our test is a non-regulatory human cell-based method, using human dermal fibroblasts in animal product-free culture conditions, and assesses membrane damage (Neutral Red Uptake method) as an endpoint. The output of the test is an IC50 value (time taken to reduce the viability of the cells by 50%) as an in vitro alternative to the traditional animal-based in vivo LD50. A prediction model places test items into predicted GHS classifications for human acute oral toxicity.
It has been internally validated using a panel of 20 well-defined cosmetic ingredients and is currently being extended to other chemical sectors, with funding from Innovate UK and the European Horizon 2020 programme. The test is ideal as a rapid, cost-effective early screen in product development and to generate supporting information in a weight-of-evidence approach to safety assessment.