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According to the EU REACH Regulation, article 3(28), ‘a Robust Study Summary (RSS) is a detailed summary of the objectives, methods, results, and conclusions of a full study report, providing sufficient information to make an independent assessment of the study, minimising the need to consult the full study report’.
The OECD has developed Harmonised Templates (OHT) to report the relevant information in the context of the risk assessment of chemicals, including Robust Study Summaries for several regulatory endpoints. IUCLID 64 , a software tool developed by the European Chemicals Agency (ECHA), in collaboration with the OECD, serves as the reference implementation for the OHTs, and provides data entry screens for users to provide the relevant information in an agreed format, within a regulatory context
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