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ECHA | Request to the Committee for Risk Assessment to set a DNEL for 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate (DOTE)

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Background - Since 2012, RAC recommends DNELs and dose response relationships for Annex XIV substances prior to receiving applications for authorisation (AfAs). The DNELs and dose response (DR) relationships serve as non-legally binding ‘reference values’. They provide applicants with a clear signal as to how RAC is likely to evaluate these key elements of the risk assessment of an application. Reference values in the form of DNELs for threshold substances and/or dose response relationships for non-threshold (mainly) carcinogens are published in advance of applications for authorisation, so providing greater consistency and better use of the legally defined periods (e.g. the latest application date). DOTE has been listed in the Annex XIV to REACH by the Commission Regulation (EU) 2022/586 of 8 April 2022 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance). The substance has been listed due to its intrinsic property referred to in Article 57c - Toxic for reproduction (category 1B). The Regulation sets the Latest application date on the 1 st November 2023 and the Sunset date on the 1 st May 2025.


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