ECHA has published advice to registrants on how to reliably combine different sources of alternative data when assessing skin sensitization of chemicals. This reduces the need to test on animals, while protecting people from allergies. The advice is based on a recent OECD guideline.
First Guideline Issued by ECHA
The OECD guideline informs REACH registrants on how to reliably combine different sources of non-animal data on skin sensitization properties of their substances. This is the first guideline issued by ECHA, outlining how to use in silico tools (using computer simulation), such as the QSAR Toolbox to assess skin sensitization.
Mike Rasenberg, ECHA’s director for Hazard Assessment said: “
This is an important milestone for advancing the use of alternative methods to assess chemical hazards. With the new guideline, we make sure that this approach can be used to protect people against skin sensitization, without the need to conduct tests on animals. ECHA contributed significantly to its development in close cooperation with the OECD, Joint Research Centre and other organizations.”
Assess Skin Sensitization Potency
The guideline contains defined approaches for assessing whether a substance is a skin sensitizer, and categorizing whether the sensitization is strong or moderate. This categorization is especially important, as REACH requires skin sensitization potency to be assessed. If the defined approach results in a conclusion on skin sensitization and potency, it can replace the currently used in vivo method Local Lymph Node Assay, reducing testing on animals.
Using the guideline helps registrants who have already submitted in chemico or in vitro data in their registrations but are uncertain whether this data is accepted by regulators. ECHA encourages those registrants to check whether they can use the defined approaches for their substances to make conclusive predictions and update their dossiers accordingly. If registrants cannot make conclusive predictions, they may need to generate new data or use a weight of evidence approach. The guideline also helps registrants select the most suitable tests to generate new data for substances.
Source: ECHA