Registration Dossier
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EC number: 203-868-0 | CAS number: 111-42-2
Toxicity to terrestrial plants
Administrative data
Link to relevant study record(s)
Description of key information
Effect values (EC50) in a seedling emergence test (Alfalfa, Barley, Northern Wheatgrass) were > 1000 mg/kg soil dw.
Key value for chemical safety assessment
- Short-term EC50 or LC50 for terrestrial plants:
- 1 632 mg/kg soil dw
Additional information
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. 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.
Assessment
A seedling emergence study with three plant species (dicots: Alfalfa; monocots: Barley, Northern Wheatgrass) was performed according to a guideline by Environment Canada (PTAC, 2006). A series of 10 test item concentrations was tested (252 to 15000 mg/kg soil dw) in addition to a control. Analytical monitoring was not performed. Observed endpoints were emergence, shoot length and mass as well as root length and mass. Only those endpoints are evaluated which are in accordance with OECD 208: emergence, shoot length and biomass. Effects on Alfalfa and Northern Wheatgrass were determined after 21 d of exposure, while the exposure period of Barley was 14 d.
It can be concluded that Alfalfa was the most sensitive species to diethanolamine (EC50 = 1632 mg/kg soil dw, shoot dry mass). All observed effect values were above the normally used highest tested concentration of 1000 mg/kg soil dw.
The test substance is not supposed to be directly applied to soil and an indirect exposure to soil is unlikely since the substance is readily biodegradable. For substances being considered as readily biodegradable, it can be assumed that they will be biologically degraded within the STP process. In special cases, if the substance is not entering the STP process but is readily biodegradable, it can be assumed that it will be rapidly biological degraded in the surface water. In both cases, a transfer to the soil compartment is unlikely.
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.
Therefore, no additional tests on terrestrial plants are provided.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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