Scientific basis for safety factors under REACH

Summary

Based on an existing database, set up by the Fraunhofer Gesellschaft, the project aims at refining the safety factors for time extrapolation, interspecies extrapolation and route-to-route extrapolation (oral-to-inhalation and oral-to-dermal). Based on the outcome of the research a table with safety factors relevant to surfactants will be proposed.

Background

Within REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals – Regulation (EC) No 1907/2006 ), the risk assessment of chemicals requires the application of safety factors to extrapolate from available animal-testing to human-health thresholds for specific use cases (e.g. chronic dermal or short-term inhalation). These human-health thresholds represent doses at which the use of the chemical is regarded as safe. While the existing animal-testing data used in risk assessment may not be available for the required time period or route of administration, safety factors have to be applied to account for these differences in the risk assessment. For human health risk assessment of surfactants the inhalation route as well as the dermal route are of special importance.

Outcome of research

Safety factors are an important component of risk assessment within regulations such as REACH. While the default safety factors proposed by the chemical legislation tend to be conservative, the current project aims at the development of safety factors for endpoints that are highly relevant for surfactants.