Challenge 5: Improved in vitro to in vivo extrapolation in chemical safety risk assessment of human systemic toxicity

Budget: £1,000,000

The safety assessment of new chemicals across the industrial chemical, agrochemical, pharmaceutical and consumer product sectors has long relied on high dose treatments in animals with default methods for extrapolating observed results to low level exposures in human populations. These traditional ‘whole-animal’ methods are expensive, can use many animals, and can sometimes be misleading with respect to human safety risk.

This Challenge focuses on safety risk assessment based on data relevant to human use rather than on predicting animal toxicity data. As such, a solution to this Challenge could ultimately provide tools and a means to address safety without the use of animals.

The aim is to develop a model that provides understanding of the relevance of toxicity concentration response data from human in vitro systems to predictions of safety following relevant in vivo human exposure. The model should focus on assessment of systemic toxicity rather than localised endpoints such as skin or eye irritation and should deliver new understanding of exposure parameters in vitro and how these relate to safe human doses.