Publications

(Q)SAR in Regulatory Praxis

Experience of a Service Provider

According to REACH Annex XI, 1.3, “Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence or absence of a certain dangerous property”. These results can be used instead of testing if certain relevant conditions are met.

In the regulatory praxis of our company, submitting dossiers of a large number of chemicals in REACH Phase I (until Nov 2010) and II (until May 2013), (Q)SAR techniqueswere often used and incorporated in registration strategies. In particular, results obtained from (Q)SAR models were submitted and accepted as key values, supportinginformation, or contributions to the weight of evidence approach. The endpoints addressed included mainly physico-chemical and environmental fate related propertiesand furthermore to less extent ecotoxicological and human toxicity information.

We present a summary of (Q)SAR use by our company throughout the REACH registration Phases I and II.

Event: 16th International Workshop on QSAR in Environmental and Health Sciences. Milan, Italy, June 16-20 2014