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Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

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Endpoint:
biodegradation in water: simulation testing on ultimate degradation in surface water
Data waiving:
other justification
Justification for data waiving:
other:
Transformation products:
not measured
Endpoint:
biodegradation in water: sediment simulation testing
Data waiving:
other justification
Justification for data waiving:
other:
Transformation products:
not measured

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.


Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) has a low water solubility (< 0.00017 mg/L at 20 °C at pH ca. 7). Thus, it is technically very difficult to conduct a study for this substance. According to Column 2 of Annex IX 9.2.1.2 of Regulation (EC) No 1907/2006 simulation testing in surface water is not required if the substance is highly insoluble in water.


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 sediment, 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 aquatic and sediment compartments is very low, which reduces the probability of exposure, in particular long-term exposure, of aquatic and sediment 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. 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 tests for biodegradation in water and in sediment are needed:
- A new enhanced ready biodegradability study (extended to 60 days) is planned for the substance.
- Simulation testing in surface water is not required if the substance is highly insoluble in water.
- Discharged concentrations of the substance into the aquatic and sediment compartments 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”.