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EC number: 221-338-7 | CAS number: 3069-40-7
Testing for long-term toxicity to fish is not considered necessary because:
Due to the rapid hydrolysis of the substance, the chemical safely assessment is based on the silanol hydrolysis product octylsilanetriol.
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.184.108.40.206 (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 justifiable.
The substance is highly water-soluble, has low bioavailability (based on log Kow <3 (1.1)) 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 nominal concentrations up to 100 mg/L) would be considered unlikely.
Based on the aquatic data set, read across from structurally similar substances, no effects were seen in the short-term fish or algal studies up to nominal concentrations of 100 mg/L. Effects were seen in the long-term invertebrate test and the result from this test is used to derive aquatic PNEC.
A PNEC has been derived for the purpose of chemical safety assessment. An assessment factor of 100 was applied to derive the freshwater PNEC. 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 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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