Draft Updated Test Guideline 497 for inclusion of SARA-ICE Defined Approach for derivation of Quantitative Point of Departure

A Defined Approach (DA) consists of a selection of information sources (e.g., in silico predictions, in chemico, in vitro data) used in a specific combination, and resulting data are interpreted using a fixed data interpretation procedure (DIP) (e.g., a mathematical, rule-based model). DAs use methods in combination and are intended to overcome some limitations of the individual, stand-alone methods. Currently, OECD Test Guideline 497 contains three DAs to come to a rules-based conclusion on potential dermal sensitisation hazard and its potency. The Test Guideline may be subject to update for inclusion of new DAs based on added values for their use in regulatory applications. 

Written comments on the draft updated TG 497 can be submitted to the OECD Secretariat for Test Guideline Programme via national coordinators (WNT) representing OECD member states. Experts from the business and industry should send their comments to the Business and Industry Advisory Committee (BIAC).  

• The draft updated TG 497 for inclusion of SARA-ICE DA for quantitative risk assessment with point of departure
• The draft Appendix 2 on SARA-ICE Technical Specification
• The draft Appendix 3 on evaluation of the SARA-ICE Point of Departure
• The draft Annex 3 on SARA-ICE Protocol for the Containerised Model/Usef Interface