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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, 2014) are used as information to decide whether Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates (CAS 91052-16-3) may potentially fulfil the PBT or vPvB criteria.

Persistence Assessment

Based on the available data, Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates (CAS 91052-16-3) 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 Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates 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 - 34.81 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 target substance is not considered to be B or vB.

Toxicity Assessment

Aquatic toxicity data for the assessment of Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates (CAS 91052-16-3) were taken from structurally similar source substances (except for long-term testing to aquatic invertebrates). All available chronic data did not result in an effect concentration of < 0.01 mg/L. Moreover, the substance is not classified according to Regulation (EC) No 1272/2008 (CLP) considering the 6th 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.