Registration Dossier
Registration Dossier
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EC number: 219-784-2 | CAS number: 2530-83-8
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Description of key information
Key value for chemical safety assessment
Additional information
Due to the rapid hydrolysis of the substance, the chemical safely assessment is based on the intermediate silanol hydrolysis product [3-(2,3-epoxypropoxy)propyl]silanetriol.
In accordance with Column 2 of REACH Annex X, 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.7.8.4.3 (ECHA, 2017), 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 justifiable.
The substance is highly water-soluble and has low bioavailability (based on log Kow <3 (-2.6)).
Based on the short-term aquatic data set the most sensitive trophic level is fish. Despite long-term Daphnia reproduction test data being available, as well as an algal NOEC, risk characterisation is based on the short-term toxicity to fish data, from which a PNEC has been derived for the purpose of chemical safety assessment. An assessment factor of 100 was applied to derive the freshwater PNEC using the short-term fish result. The fact that the PNEC is based on the most sensitive species means it is unlikely that the aquatic PNEC would be significantly over-estimated.
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 ratios 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.
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