Registration Dossier
Registration Dossier
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EC number: 615-229-7 | CAS number: 70969-57-2
Biodegradation in soil
Administrative data
Link to relevant study record(s)
- Endpoint:
- biodegradation in soil: simulation testing
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Transformation products:
- not measured
Reference
Description of key information
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
Key value for chemical safety assessment
Additional information
The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly.
The substance is not readily biodegradable within 28 days based on a ready biodegradability test with an analogue substance. Therefore, a new enhanced ready biodegradability study (extended to 60 days) is planned for the substance to investigate further its P/vP potential. The finalised study will be included in the technical dossier and the hazard assessment for biodegradation will be re-evaluated based on the study results. Therefore, no further degradation studies are proposed currently.
As a result of the high adsorption potential (log Koc > 5) of Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) a removal from the water column to a significant degree by adsorption to sewage sludge can be expected (Guidance on information requirements and chemical safety assessment, Chapter R.7b, (ECHA, 2017)). Thus, only limited amounts will get in contact with activated sludge organisms in STPs and the concentration of the substance in effluents of conventional STPs is presumably marginal. Furthermore, in a toxicity control of a biodegradation study for a suitable analogue substance no inhibition of sewage sludge microbial activity has been observed (40.9% after 14 d). Thus, the degradation process in commercial sewage treatment plants is not suspected to be inhibited by the target substance. Thus, release of the substance into the surface waters, and thereby exposure of soil, is likely to be negligible. Considering this, one can assume that the availability of Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) in the soil compartment is very low, which reduces the probability of exposure, in particular long-term exposure, of soil organisms in general.
Aerial deposition can be considered negligible, since Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is not volatile based on a vapour pressure value of 1.86E-6 Pa at 20 °C.
Based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017) the substance is not bioaccumulative. Because, based on the physico/chemical properties of Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) such as low water solubility and high potential for adsorption a reduced availability in water is expected. Additionally, bioaccumulation potential is low due to metabolism and high molecular weight. Thus, if bioaccumulation could be excluded, the evaluation of the persistence (P) is not relevant and the overall evaluation result is “not PBT”.
In conclusion, based on the following reasons no simulation test for biodegradation in soil is needed:
- A new enhanced ready biodegradability study (extended to 60 days) is planned for the substance.
- Discharged concentrations of the substance into the soil compartment are likely to be negligible.
- Aerial deposition can be considered negligible.
- The substance is not bioaccumulative and therefore the evaluation of the persistence (P) is not relevant as the overall evaluation result is “not PBT”.
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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