08.02.2017

Updates concerning testing for sensitisation

In December 2016 the updated Endpoint specific guidance R.7a was published including changes concerning skin and respiratory sensitisation. In terms of mechanistic understanding, skin sensitisation is well understood and key events occurring are mapped within the Adverse Outcome Pathway. Based on that, for several key events in vitro/in chemico testing guidelines (OECD TG 442 C/D/E) are now available. The updated guidance takes into account these in vitro/in chemico tests as well as in silico approaches and presents an Integrated Approach to Testing and Assessment (IATA). This IATA is in accordance with the revised Annexes VII and VIII of the REACH Regulation (Commission Regulation (EU) 2016/1688), in which in vitro/in chemico testing are standard requirements and in vivo testing is only last resort. With the currently validated in vitro/ in chemico testing guidelines only hazard identification is possible, according to CLP potency assessment is required, yet. Potency assessment is currently subject of research.

In case you have any questions please contact our expert Karin Heine.