Registration Dossier
Registration Dossier
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EC number: 500-288-2 | CAS number: 103213-20-3
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Data for the definitive conclusion on the PBT or vPvB properties according to the criteria set in Regulation (EC) No. 1907/2006, Annex XIII, parts 1 and 2, are not available for all three criteria. Thus, the screening criteria given in the ‘Guidance on information requirements and chemical safety assessment - Chapter R.11: PBT assessment’ (ECHA, 2012) are used as surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB criteria.
Persistence Assessment
Based on the available data, Fatty acids, C18-unsatd, dimers, hydrogenated, diisopropyl esters is not readily biodegradable. Thus, the substance may potentially fulfil the P/vP criteria.
Bioaccumulation Assessment
The bioaccumulation potential of Fatty acids, C18-unsatd, dimers, hydrogenated, diisopropyl esters is expected to be low. This assumption is based on the physico/chemical properties such as low water solubility and high potential for adsorption a reduced availability in water is expected. The high molecular weight of the substance significantly reduces the absorption due to steric hindrance to cross biological membranes. It can be concluded that the bioaccumulation potential of Fatty acids, C18-unsatd, dimers, hydrogenated, diisopropyl esters is negligible. BCF/BAF values estimated by QSAR (BCFBAF v3.01) also support this assumption (BCF values all well below 2000 L/kg). Please refer to IUCLID section 5.3 for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the substance is not considered to be B or vB.
Toxicity Assessment
Data on the aquatic toxicity of the substance are only available for short-term toxicity to fish. The assessment is therefore based in part on read across data. All available data demonstrate no toxicity up to the water solubility limit. Moreover, the target substance and the source substance used to predict environmental toxicity are not classified according to Regulation (EC) No 1272/2008 (CLP) considering Regulation (EU) No 605/2014 (5th ATP). Thus, the criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2014) are not met and the target substance as well as the source substance are not considered to meet the T criterion.
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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