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A 14-day LC50 of >1000 mg/kg dry weight and NOEC of ≥1000 mg/kg dry weight have been determined for the effects of the test substance on mortality of Eisenia fetida. A NOEC of ≥1000 mg/kg dry weight has also been determined for effects on growth. It is likely that under the moist test conditions employed in the test that the test organisms were exposed to the hydrolysis products of the substance.

In accordance with Column 2 of REACH Annex IX, there is no need to further investigate the effects of this substance in long-term terrestrial toxicity to invertebrates/higher plants 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 further testing is not necessary for the following reasons:

The substance hydrolyses rapidly and its hydrolysis product has a log Kow <3 (-4.0 (corrected for ionisation)), therefore has low potential for bioaccumulation, and partitioning to the terrestrial compartment is expected to be minimal. Preliminary observations from ongoing experimental work (pers. comm. 2017) indicates rapid decline of the substance and its hydrolysis products in standard soils, suggesting there is no indication for high persistence.

In the context of the Integrated Testing Strategy for the terrestrial compartment (terrestrial hazard classification scheme, Table R.7.11—2) the aquatic toxicity tests do not indicate that the substance is very toxic (EC/LC50 > 1 mg/L for algae, daphnia and fish).

A short-term toxicity test has been carried out with Eisenia foetida where no effects were observed at the highest tested concentrations (>1000 mg/l).

The soil hazard category 1 (ECHA 2016, guidance part R7(c) Table R.7.11—2) has been derived for the substance. In accordance with the screening assessment for soil hazard category 1 substances, a PNECsoil has been calculated from the aquatic data on the basis of the equilibrium partitioning method. The PNEC derived by Equilibrium Partitioning has been derived for the purpose of deriving a 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.