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Ecotoxicological information

Toxicity to terrestrial arthropods

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No relevant data available.

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Only one valid study was performed by Yoon et al. (1985). The test was conducted comparable to OECD TG 477. As this test is usually used for testing on genotoxic effects on fruit flies (Drosophila spec.) lethal effects of substances may be tested in parallel. The test organisms were fed with with a stock solution of known concentration. After 3 days of exposure, a mortality of 48% (= LC48) was reported for a concentration of ca. 33300 mg/l.

However, this test cannot be used for the derivation of the PNECsoil, since Drosophila adult male animals were treated with the test substance at rather high concentrations. Interaction with soil was not guaranteed and therefore, it may not be concluded, that the exposure path was the one required for the derivation of the PNECsoil. Therefore, the study was disregarded.

Annex IX and X, Section 9.4, Column 2 and Annex XI, Section 3

No relevant studies on terrestrial organisms are available for the substance.

According to Regulation (EC) 1907/2006, Annex IX, Section 9.4.1 to 9.4.3, Column 2, studies on the toxicity to terrestrial organisms do not need to be conducted as the substance is considered to be readily biodegradable. The test substance is not supposed to be directly applied to soil. An indirect exposure to soil via sewage sludge transfer is unlikely since the substance is readily biodegradable (for details see IUCLID Ch. 5.2.1). For a substance being considered as „readily biodegradable“, it can be assumed that it will be biodegraded within the STP process and as a consequence a transfer to the soil compartment is not expected. In addition, the substance is expected to rapidly degrade in soil, as indicated by a half-life of 1.8 d determined in a degradation test in soil (see IUCLID Ch. 5.3.3).

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 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. Based on the low log Kow and the low measured and 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”). However, no risk assessment is required as the substance holds no relevant classification for toxicity or environmental effects. In addition, short-term and long-term hazards are not expected (L(E)C50 > 100 mg/L; NOEC/EC10 > 1 mg/L).

Consequently, no tests on soil organisms are performed. The equilibrium partitioning method has been used for assessing the hazard to soil organisms in accordance with Annex IX and X, Section 9.4, Column 2 of Regulation (EC) No 1907/2006.