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Toxicity to soil microorganisms

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In accordance with REACH Regulation (EC) 1907/2006, Annex IX and X, Section 9.4., Colum 2, the toxicity testing to terrestrial organisms shall be proposed depending on the results 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 hazardous according to Regulation EC 1272/2008 and its second adaptation 286/2011 or is assessed to be a PBT or vPvB. The hazard assessment of diethanolamine 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 soil is unlikely since the substance is readily biodegradable according to OECD criteria. For substances being considered as „readily biodegradable“, it can be assumed that they will be completely biologically degraded within the STP process. Indirect exposure to soil is not likely e.g. via agricultural use of sewage sludge since diethanolamine is readily biodegradable (see IUCLIC Ch. 5.2.1, BASF AG, 1992). Furthermore, for substances not passing the STP-process but being readily biodegradable, it can be assumed that they will be also biological degraded in the surface water within a short time. Direct exposure to soil is not likely, since the substance is not intentionally applied to soil. The substance has no potential to bioaccumulate (BCF = 2.7 L/kg considering all mitigating factors (9.2 L/kg not considering any mitigating factors), according to the BCF baseline model v.04.11, implemented in OASIS Catalogic v5.14.1.5, (BASF SE, 2021). Regarding the charged molecule at pH 7 the log Koc was estimated to be 0.99 (Koc = 10 L/kg) following the method of Franco & Trapp, 2008, 2009, 2010 (BASF, 2021). Therefore, adsorption to solid soil phase is not expected (log Koc < 3).

In conclusion no testing is required. As a consequence, no tests on soil microorganisms are provided. The predicted no effect concentration (PNEC) for soil was derived by applying an assessment factor of 1000 to the lowest EC50 according to REACH Guidance R.10.6.2 as results are available from short-term tests with a producer, a consumer and a decomposer.