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Ecotoxicological information

Long-term toxicity to fish

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Reference
Endpoint:
fish early-life stage toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

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.