Registration Dossier
Registration Dossier
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EC number: 246-625-4 | CAS number: 25111-05-1
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014d) are used as information to decide whether 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1) may potentially fulfil the PBT or vPvB criteria.
Persistence Assessment
Based on the available data, 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1) is considered to be readily biodegradable based on experimental data. Thus, the substance does not meet the screening criterion for persistence and is not considered to be P or vP.
Bioaccumulation Assessment
The bioaccumulation potential of 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1) is expected to be low. This assumption is based on a low bioavailability of the substances due to its ready biodegradability, high adsorption potential and low water solubility. Furthermore, the substance is rapidly metabolised and excreted by organisms and thus significant accumulation is not expected. This is supported by calculated low BCF/BAF values of 0.89 - 18.94 (BCF: Arnot-Gobas estimate, upper trophic) and 0.89 - 30 L/kg (BAF: Arnot-Gobas estimate, upper trophic), respectively.Please refer to IUCLID section 5.3for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the target substance is not considered to be B or vB.
Toxicity Assessment
Aquatic toxicity data for the assessment of 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1) were taken from structurally similar source substances. Long-term toxicity testing with aquatic algae and aquatic invertebrates resulted in no effects up to the limit of water solubility. All available short-term toxicity data did not result in any toxicity up to the water solubility limit as well. Moreover, the substance is not classified according to Directive 67/548/EEC and Regulation (EC) No 1272/2008 (CLP) considering Regulation (EU) No 605/2014 (5th ATP). Thus, given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014) are not met and the substance is not considered to meet the T criterion.
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