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Classification & Labelling & PBT assessment

PBT assessment

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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, 2012) are used to decide whether Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol may fulfil the PBT or vPvB criteria.

Persistence Assessment

Based on the available data, Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol is considered to be readily biodegradable. Thus, the substance does not meet the screening criterion for persistence and it is not considered to be P or vP.

Bioaccumulation Assessment

The bioaccumulation potential of Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol is expected to be low. This assumption is based on a low bioavailability of the substances due to its ready biodegradability, high adsorption potential, high log Kow and low water solubility. Furthermore, the substance is expected to be metabolised and excreted by organisms and thus significant accumulation is not expected. This is supported by calculated low BCF/BAF values of 0.893 - 24.68/0.893 - 24.69 L/kg (Arnot-Gobas estimate, upper trophic), respectively. Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the test substance is not considered to be B or vB.

Toxicity Assessment

Long-term toxicity testing with aquatic algae and daphnia 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, Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, tri- and tetraesters with pentaerythritol is not classified according to Regulation (EC) No 1272/2008 (6th ATP). Thus, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.

The test substance is not classified according to Regulation (EC) No 1272/2008 (6th ATP).

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