Toxicological guidance and limit values are one of the key instruments in regulatory toxicology. Their derivation allows a direct comparison with exposure levels and – as a consequence of such comparison – drawing conclusions for risk management (e.g. DNEL derivation in REACH registration dossiers, triggering risk management measures in the chemical safety report). Responsible handling of toxicological guidance values, however, also includes a communication of limitations and uncertainties in relation to their validity.
FoBiG demonstrated the expertise for deriving limit values in many different projects. In this context, various projects on methodological issues have helped us to develop a deeper understanding of options for deriving such values and their validity.
Different regulatory areas require different methodological approaches and guidance values, such as