…Read-across for multi-constituent substances and UVCBs

Read-across is one of the most commonly used non-test methods for data gap filling under REACH, and involves the use of information on analogous (structurally-similar) compounds, metabolites or precursors (source substances) to predict the properties of a target substance. Any read-across approach must be appropriate and well-justified, and ECHA has developed a read-across assessment framework (RAAF) to assess such predictions internally, and to help registrants develop and appropriately document read-across cases that comply with REACH. Mono-constituent substances are the focus of the RAAF, but it can also be applied to mixtures and to UVCBs (substances of unknown or variable composition, complex reaction products or biological materials). To identify the additional issues that may be encountered when applying the RAAF to multi-constituent and UVCB assessments, ECHA has issued this report which stresses the importance of substance definition and provides model cases which have been constructed and analysed.

European Chemicals Agency (2017). Read-Across Assessment Framework (RAAF). Considerations on multi-constituent substances and UVCBs. ECHA-17-R-04-EN. https://echa.europa.eu/documents/10162/13630/raaf_uvcb_report_en.pdf/3f79684d-07a5-e439-16c3-d2c8da96a316

 

…More guidance on nanomaterial assessment

ECHA has drafted a revision of its appendix relating to the human health data requirements for nanomaterials under REACH, which includes updated sections on mutagenicity and repeated dose toxicity.

European Chemicals Agency (2017). Guidance on information requirements and Chemical Safety Assessment. Draft Appendix R7-1 Recommendations for nanomaterials applicable to Chapter R7a Endpoint specific guidance and Appendix R7-2 Recommendations for nanomaterials applicable to Chapter R7c Endpoint specific guidance. Draft (Public) Version 2.0. February 2017. https://echa.europa.eu/documents/10162/13643/nano_ir_human_health_caracal_en.pdf/dcee7ddc-fc2d-28bf-ebce-0fdf270cf878

 

OECD report on alternative testing strategies in risk assessment of nanomaterials

A number of experts from academia, industry, government and public interest groups have evaluated how “alternative models” could be used to advance the risk analysis of manufactured nanomaterials. Subsequently, the Organisation for Economic Co-operation and Development has released a report describing the state of the science on alternative testing methods for the risk assessment of these unique substances. A major finding was that alternative testing strategies are now being used for screening, and could be further developed for use in read-across decision making within certain regulatory frameworks.

Organisation for Economic Co-operation and Development (2017). Alternative testing strategies in risk assessment of manufactured nanomaterials: current state of knowledge and research needs to advance their use. Series on the Safety of Manufactured Nanomaterials No. 80. ENV/JM/MONO(2016)63. http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/JM/MONO(2016)63&doclanguage=en

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