Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

Testing for long-term toxicity to invertebrates is not considered necessary because:

Due to the rapid hydrolysis of the substance, the chemical safely assessment is based on the silanol hydrolysis product 3-(trihydroxysilyl)propyl methacrylate.

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 invertebrates study because, as indicated in guidance R.7.8.4.3 (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 justifiable.

The substance is highly water-soluble and has low bioavailability (based on log Kow <3 (-0.9)). 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, the most sensitive trophic level is algae.

A PNEC has been derived for the purpose of chemical safety assessment. An assessment factor of 1000 was applied to derive the freshwater PNEC, this high assessment factor to derive the predicted no-effect level already reflects the typically higher value of a short-term EC50 compared to a long-term EC10. It is, therefore, 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.

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.