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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

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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, 2014) are used as information to decide whetherFatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2)may potentially fulfil the PBT or vPvB criteria.

Persistence Assessment

Based on the available data, Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2) 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, 2-ethylhexyl esters (CAS 68440-06-2) 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, 2-ethylhexyl 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

Aquatic toxicity data for the assessment of the substance were taken from a structurally similar source substance. All available data did not result in any toxicity up to the water solubility limit. Moreover, the target substance and the source substance used to predict environmental toxicity is 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.