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Ecotoxicological information

Toxicity to terrestrial arthropods

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In Annex X Section 9.4 of Regulation (EC) No 1907/2006, it is laid down that tests on terrestrial organisms shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on terrestrial organisms. According to Annex IX and X, the choice of the appropriate tests depends on the outcome of the chemical safety assessment. Since invertebrates were the most sensitive group as indicated from aquatic toxicity data, a chronic earthworm study was performed to cover this endpoint in accordance with REACh guidance for compounds in soil hazard category 3 (ECHA, Guidance on Information Requirements and Chemical Safety Assessment, Version 3.0, June 2017, Chapter R.7c, Table R.7.11 -2). In addition the toxicity to soil microorganisms was tested in a nitrogen transformation test according to OECD 216. In Annex XI Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 10).   Consequently, no further tests on soil organisms are performed. The PNEC was derived using the available experimental data on terrestrial toxicity.