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Long-term toxicity to aquatic invertebrates

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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 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 below 1, even with due consideration of contributing uncertainties, and therefore the risk is already adequately controlled and further testing is not justifiable.

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 EC50compared to a long-term EC10. 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.