Practical Guide 5: How to report (Q)SARs - ECHA - Europa

prediction should be fit for the regulatory purpose, and (iv) the information should be well
documented. An assessment of the first three points above is expected to be included in
the registration dossier if substance properties are predicted using (Q)SAR models. In
case there is not sufficient information to address all of them, a prediction could be used
as part of a weight-of-evidence approach or as supporting information. The closer the
outcome is to a regulatory decision point (e.g. classification of a substance as hazardous
versus non classification), the more accurate predictions or a more detailed justification
is needed. The consequences of a wrong decision based on predicted properties will
indicate how much uncertainty for the prediction can be accepted.
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