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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:

Sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated) is assumed to be readily biodegradable based on two studies on read across substances (62.5 to 88%). Thus, the substance does not meet the screening criterion for persistence and it is not considered to be persistent (P) or very persistent (vP).

According to QSAR calculation with the main constituents of the target substance sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated), showed log Kow values of 4.02 – 20.76 (KOWWIN v1.68) indicating partially a potential for bioaccumulation. However, BCFBAF (v3.01) calculations resulted to BCF values between 0.89 and 14.6 L/kg for the main constituents, indicating a low potential for bioaccumulation (Arnot-Gobas method, including biotransformation). An exclusion of biotransformation resulted in higher BCF values of 0.893 - 1082 L/kg, indicating that extensive metabolism occurs and significantly reduces the bioaccumulation potential in a short period of time. The QSAR estimated biological half-life is 0.01 – 14.93 d. The higher molecular weight components of the substance are not within the applicability of the model and the calculated BCF values should be taken with caution. Nevertheless, they are expected to have a limited potential for bioaccumulation. According to ECHA Guidance R.11 (ECHA, 2014) substances with high molecular weight (> 1100 g/mol) and high log Kow (> 9.3) are expected to have a reduced potential for bioaccumulation and are not likely to meet the B criterion. The substance components which are not in the applicability domain of the model exhibit a molecular weight of 1032 – 1492 g/mol and high log Kow values of 11.33 - 20.76. Thus, they are not expected to have a significant potential for bioaccumulation. Furthermore, the substance can be digested by metabolic hydrolysis and other common metabolic pathways, which enhances the assumption of no bioaccumulation in organisms. For a detailed review on metabolism of the substance, please refer to the toxicokinetics statement in IUCLID section 7.1. Thus, taking all information into account, the substance is not considered to be bioaccumulative (B) or very bioaccumulative (vB).

Long-term toxicity testing with Daphnia magna resulted in a NOELR (21 d) of 10 mg/L for the source substance sorbitan monolaurate, ethoxylated (CAS 9005-64-5). Moreover, the target substance 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 sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated) is not considered to meet the T criterion.