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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for Sorbitan monolaurate, ethoxylated (CAS No. 9005-64-5) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).

Persistence

Sorbitan monolaurate, ethoxylated (CAS No. 9005-64-5) is readily biodegradable according to OECD 301 F (62.5% (O2 consumption) after 28 d). Thus, Sorbitan monolaurate, ethoxylated does not meet the screening criterion for persistence and is not considered to be P or vP.

Bioaccumulation

Based on the BCF values of 1.2 - 7.1, calculated using the Arnot-Gobas method, including biotransformation (BCFBAF v3.01), a relevant uptake and bioaccumulation in aquatic organisms is not expected for Sorbitan monolaurate, ethoxylated.

Toxicity

No effects occurred in the long-term toxicity test with Daphnia magna (OECD 211) with Sorbitan monolaurate, ethoxylated up to the test concentration of 10 mg/L (NOEC = 10 mg/L). Moreover, Sorbitan monolaurate, ethoxylated is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and Sorbitan monolaurate, ethoxylated is not considered to meet the T criterion.