ECHA published an advice on using the OECD Guideline focusing on how to reliably combine different data from non-animal studies to assess skin sensitization of chemicals.
The new guideline will help companies to reduce animal testing, by relying on new in vitro methods that can be used to protect the population from allergies caused by chemicals.
This is the first guideline that also describes the use of in silico tools (computer simulation) for the assessment of skin sensitization. The guideline contains defined approaches to evaluate whereas the substance is a skin sensitizer and to categorize the potency, relevant for the REACH registration.
The use of the guidelines may help registrants who have already submitted in vitro data in the registration dossiers, but are uncertain whether they will actually be accepted by the regulators. ECHA encourages those registrants to monitor whatever they can use the defined approaches for their own substances to make conclusive predictions, and update their dossiers accordingly. If the evaluation does not lead to conclusive predictions, registrants will have to generate new data or use a weight of evidence approach. The guideline also helps registrants to select the most suitable test to generate new data for substances.
ECHA’s advice for registrants on how to use the new guideline can be found at this link.