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Environmental fate & pathways

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No experimental studies investigating the bioaccumulation potential of sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated) are available. Therefore, the bioaccumulation factor (BCF) of the substance was estimated using a reliable QSAR model (BCFBAF v3.01). Using the Arnot-Gobas method, including biotransformation (BCFBAF v3.01), BCF values from 0.89 to 12.5 L/kg were calculated for the main constituents of the substance (Adaktylou, 2016). The substance is partially not in the applicability domain of the Arnot-Gobas model indicating that the results have to be taken with caution. Only the smallest component (C16 sorbitan monoester) is within the applicability domain of the model and thus, the BCF (12.5 L/kg) is fully reliable. However, according to ECHA Guidance R.11 (ECHA, 2014) a molecular weight higher than 1100 g/mol and a log Kow higher than 10 are indicators that the aquatic BCF of a respective substance is lower than the trigger value of 2000 to be classified as bioaccumulative. Therefore, no bioaccumulation is expected for the remaining three constituents either. Furthermore, the substance can be digested by metabolic hydrolysis and other common metabolic pathways, which enhances the assumption of low bioaccumulation into organisms. For a detailed review on metabolism of the substance, please refer to the toxicokinetics statement in IUCLID section 7.1. Consequently, it can be concluded that sorbitan C16-18 (even numbered) fatty acid esters, ethoxylated (1-6.5 moles ethoxylated) has a low potential for bioaccumulation.