Route to Route Extrapolation Factors for Regulatory Risk Assessment – a Probabilistic Approach

Introduction

EUROTOX 2014, 7th – 10th September 2014, Edinburgh International Conference Centre In human risk assessment any relevant exposure route (oral, inhalation and dermal) has to be addressed. Usually only oral studies are conducted while inhalation and dermal studies are not available. Avoiding additional testing according to the 3R principles (Reduction, Refinement and Replacement of animal testing), route-to-route (R2R) extrapolation factors (EF) can be applied to derive the route-specific no-adverse-effect-level (NOAEL). One prerequisite for this approach is the use of scientifically sound extrapolation factors, which are based on a high quality and broad data basis.