Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

In accordance with Column 2 of REACH Annex X, there is no need to further investigate the effects of this substance and it’s hydrolysis products in a long-term terrestrial toxicity to microorganisms study because, as indicated in guidance R.7.11.6 (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 PNECsoil has been calculated from the aquatic data on the basis of the equilibrium partitioning method. The PNEC calculated by Equilibrium Partitioning has been derived for the purpose of chemical safety assessment and the risk characterisation ratios are below 1.

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.