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EC number: 219-764-3
CAS number: 2526-62-7
Testing for toxicity to terrestrial organisms
is not considered necessary because:
In accordance with Column 2 of REACH Annex IX, there is no need to
further investigate the effects of this substance in a long or
short-term terrestrial toxicity study because, as indicated in guidance
R.7.11.6 (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 not justifiable.
The silanol hydrolysis product is not readily biodegradable but has low
potential for bioaccumulation (based on log Kow <3
(-2.9)) and there is no reason to expect any specific mechanism of
toxicity beyond narcosis. The low log Kow indicates
that partitioning to the terrestrial compartment is expected to be
Short-term toxicity testing has been carried out with a structural
analogue of the registered substance. During these tests, it is likely
that organisms were exposed to the parent substance and some hydrolysis
product of the test substance during the fish and Daphnia tests,
and mostly the hydrolysis products during the algal test. The occurrence
of more severe toxic effects in the terrestrial compartment that were
not expressed in these aquatic studies (conducted at concentrations of
parent substance loaded up to 120 mg/l) would be considered unlikely.
PNECsoil has been calculated from the aquatic data on the basis of the
equilibrium partitioning method. The PNEC calculated by Equilibrium
Partitioning has been derived for the purpose of chemical safety
assessment and the risk characterisation ratios are below 1.
Overall it is concluded that the risk characterisation conclusion is
sufficiently conservative in respect of any uncertainties and therefore,
further testing is not considered necessary.
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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