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Long-term toxicity to fish

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Description of key information

Key value for chemical safety assessment

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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. (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 currently not justifiable. However this will be reviewed once the results of the OECD TG 211 are available.

Due to the hydrolysis rate of the substance (<48 hours), the PNECaquatic is based on the parent substance.

Based on the short-term aquatic data set, the most sensitive trophic level is fish. Long-term data are not available and the risk characterisation is based on short-term toxicity to fish data, from which a PNEC has been derived for the purpose of chemical safety assessment. The PNEC is based on an LC50 that is thought to be conservative, due to a sharp-dose response curve and lack of interim exposure concentrations, 0% mortality was observed at the concentration value used to derive the PNEC. 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.

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 currently considered necessary or justified on ethical grounds.

The need for a long-term toxicity to fish study will be reviewed once the long-term aquatic invertebrates study becomes available.

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.