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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Description of key information

Effect values (EC50, EC25) on earthworm adult survival and reproduction were > 1000 mg/kg soil dw.

Key value for chemical safety assessment

Additional information

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.

According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as dangerous according to Directive 67/548/EEC or Regulation EC 1272/2008 or is assessed to be a PBT or vPvB.  

The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. In addition, indirect exposure to the soil compartment is unlikely since the substance is readily biodegradable according to OECD criteria (see IUCLID Ch. 5.2.1). For substances being considered as „readily biodegradable“, it can be assumed that they will be biologically degraded within the STP-process. As the log Koc and log Kow of the substance are below 3, a low adsorption potential is indicated (see IUCLID Ch. 5.4.1). Hence, an adsorption to activated sludge is unlikely. Based on the low log Kow and the low estimated BCF values, bioaccumulation in aquatic organisms is not to be expected (see IUCLID Ch. 5.3.1).  

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 tests on soil organisms are required. However, long-term toxicity studies are availabel for earthworms, collembolans and terrestrial plants. However, as these studies did not report chronic effect values (EC10, NOEC), the PNECs were derived using the EC50 values as acute data.

A chronic earthworm test was performed according to a guideline by Environment Canada (Stantec, 2006). The test species was Eisenia andrei. A series of 8 test item concentrations was tested (0.5 - 8000 mg/kg soil dw) in addition to a control. Analytical monitoring was performed. The recovery was very poor (<= 2%), which is probably due to an insufficient analytical method; however, for earthworm testing analytical monitoring is not required according to OECD 222. After 35 d the adult survival was measured. After 63 d the effects on reproduction were determined (number of progeny, wet and dry mass of individual progeny). The concentration response curve for reproduction was very steep, showing effects only for the highest test concentration of 8000 mg/kg soil dw. The report only contains EC25 and EC50 values; therefore the results are considered as acute effect values. The assessment is based on those endpoints which are considered in the relevant OECD 222 guideline (adult survival and number of progeny). The 35 -d LC50 (adult survival) was 3715 mg/kg soil dw. The EC50 for reproduction (no. of progeny) was 4033 mg/kg soil dw and the EC25 2016 mg/kg soil dw.

The PNEC soil was derived based on experimental data only according to REACH Guidance R.10.6.2 as short-term data are available for producer, consumer, and decomposer.