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EC number: 242-056-0
CAS number: 18171-19-2
Due to the rapid hydrolysis of the
substance, the chemical safely assessment is based on the silanol
hydrolysis product 3-chloropropyl(methyl)silanediol.
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.126.96.36.199 (ECHA 2016), the quantitative
chemical safety assessment (conducted according to Annex I of REACH)
indicates that the Risk Characterisation Ratio is well below 1, even
with due consideration of contributing uncertainties, and therefore the
risk is already adequately controlled and further testing is not
is highly water-soluble, has low bioavailability (based on log Kow <3
(0.8)) and there is no reason to expect any specific mechanism of
toxicity beyond narcosis. Therefore, the occurrence of toxic effects
that were not expressed in the existing short-term aquatic studies
(conducted at concentrations up to 1000 mg/l loading rate) would be
A PNEC has been derived for
the purpose of chemical safety assessment. 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.
For a narcotic chemical without a specific mode of toxic action, it is
unlikely that the aquatic PNEC would be significantly over-estimated
using this method.
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 considered necessary or justified on ethical grounds.
Details on how the PNEC and
the risk characterisation ratio have been derived can be found in IUCLID
Section 6.0/CSR Section 7.6 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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