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EC number: 252-161-3
CAS number: 34708-08-2
In accordance with Column 2 of REACH Annex IX, there is no need to
further investigate the effects of this substance in a long-term aquatic
toxicity to fish study because, as indicated in guidance R.220.127.116.11 (ECHA
2016), the quantitative chemical safety assessment (conducted according
to Annex I of REACH) indicates that the Risk Characterisation Ratio is
below 1, and therefore the risk is already adequately controlled and
further testing is currently not justifiable. However this will be
reviewed once the results of the OECD TG 211 are available.
Due to the hydrolysis rate of the substance (<48 hours), the PNECaquatic
is based on the parent substance.
Based on the short-term aquatic data set, the most sensitive trophic
level is fish. Long-term data are not available and the risk
characterisation is based on short-term toxicity to fish data, from
which a PNEC has been derived for the purpose of chemical safety
assessment. The PNEC is based on an LC50 that is thought to
be conservative, due to a sharp-dose response curve and lack of interim
exposure concentrations, 0% mortality was observed at the concentration
value used to derive the PNEC. An assessment factor of 1000 was applied
to derive the freshwater PNEC, this high assessment factor to derive the
predicted no-effect level already reflects the typically higher value of
a short-term EC50 compared to a long-term EC10.
Overall it is concluded that the risk characterisation conclusion is
sufficiently conservative in respect of any uncertainties and therefore
further in vivo testing is not currently considered necessary or
justified on ethical grounds.
The need for a long-term toxicity to fish study will be reviewed once
the long-term aquatic invertebrates study becomes available.
Details on how the PNEC and the risk characterisation ratio have been
derived can be found in IUCLID Section 6.0 and Chapters 9 and 10 of the
Chemical Safety Report, respectively.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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