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HomeAppendix for nanoforms applicable to the guidance on QSARs and Grouping of Chemicals
Guidance on information requirements and chemical safety assessment
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This appendix to Chapter R.6 of the guidance on IR&CSA has been developed in order to provide advice to registrants preparing registration dossiers that cover nanoforms (or sets of nanoforms) This document aims at providing an approach on how to justify the use of hazard data between nanoforms and/or sets of nanoforms, and the non-nanoforms of the same substance. It is presented as an Appendix to Chapter R.6 of the Guidance on IR&CSA on QSARs and Grouping because general concepts on grouping of chemicals are applicable to nanoforms. Please note that no specific advice for QSARs with respect to nanoforms is provided in this version of the guidance. The approach and general principles provided in this document, together with the advice provided in the parent guidance, may also be useful when considering read-across of studies between nanoforms and/or sets of nanoforms, of different substances. This appendix aims at providing advice specific for nanoforms but does not preclude the application of the general principles given in the parent guidance on the same matter. Please note that this document does not provide endpoint specific guidance on how to meet the information requirements set out in Annexes VI to XI to the REACH Regulation. Such information is provided in Chapters R.7a, R.7b and R.7c of the Guidance on IR&CSA and its nanospecific Appendices for nanoforms. General information on how to meet the information requirements, such as collection and evaluation of available information, and on adaptation of information requirements is available in Chapter R.2 to R.5 of Guidance on IR&CSA) and is considered to also be applicable for nanoforms.
- Published:
- Corporate author(s): European Chemicals Agency (EU body or agency)
- Themes: Industrial policy , Chemical industry , Public health
- Subject: chemical industry , chemical product , environmental risk prevention , health risk , industrial hazard , nanotechnology , public health , toxic substance , user guide
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| ISSN | ISBN 978-92-9481-161-5 | DOI 10.2823/273911 | Catalogue number ED-04-19-681-EN-N |
- Released on EU publications website:
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