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EC number: 220-449-8
CAS number: 2768-02-7
Due to the very rapid hydrolysis
of the substance, the chemical safely assessment is based on the silanol
hydrolysis product vinylsilanetriol (CAS 143-48-6).
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.188.8.131.52 (ECHA 2016), the quantitative chemical
safety assessment (conducted according to Annex I of REACH) indicates
that the Risk Characterisation Ratio is well below 1, and therefore the
risk is already adequately controlled and further testing is not
The substance is highly
water-soluble and has low potential for bioaccumulation (based on log Kow <3
(-2.0)) and there is no reason to expect any specific mechanism of
toxicity beyond narcosis. Therefore, the occurrence of toxic effects
below 100 mg/L that were not expressed in the existing short-term
aquatic studies would be considered unlikely.
Based on the short-term aquatic
data set, toxicity to fish is low; the most sensitive trophic level is Daphnia
and a long-term Daphnia reproduction test is available.
A PNEC has been derived for
the purpose of chemical safety assessment. An assessment factor of 50
was applied to derive the freshwater PNEC using the long-term Daphnia
result. The availability of the long-term result covering the most
sensitive species in the aquatic tests, and the application of an
appropriate assessment factor, means it is, therefore, unlikely that the
aquatic PNEC would be significantly over-estimated.
Based on the exposure
assessment of the registered substance, the highest PEC/PNEC for
vinylsilanetriol is 0.362/0.4 = RCR 0.904. If a long-term toxicity to
fish test were to be conducted, an assessment factor of 10 would be
applied to the results of the lowest long-term effect concentration to
derive PNECaquatic (based on the availability of three long-term
toxicity values from three trophic levels). The fish would have to
exhibit a dose response of <4 mg/l to be more conservative than the
current PNECaquatic of 0.4 mg/l derived from the chronic invertebrate
data. There is no basis to expect such toxicity for vinylsilanetriol
based on the absence of significant short-term toxicity observed in
aquatic tests, the fact that fish were the least sensitive trophic level
in the short-term aquatic tests and the low potential for
bioaccumulation of vinylsilanetriol.
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 and Chapters 9 and 10 of the Chemical Safety Report,
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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