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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 Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol (CAS 93334-10-2) 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

Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol is readily biodegradable in one study according to OECD 301 B (71.1 - 84.5% (CO2 evolution) after 28 d). Thus, the test substance does not meet the screening criterion for persistence and it is not considered to be P or vP.

Bioaccumulation

Due to the low water solubility, rapid environmental biodegradation and metabolism via enzymatic hydrolysis of Sorbitan esters, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and corresponding alcohol component. From literature it is well known, that these hydrolysis products will be metabolised and excreted in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990). QSAR calculations support the assumption of rapid metabolism within fish. Using the Arnot-Gobas method, including biotransformation, BCF values of 0.893 - 440.3 L/kg were obtained (BCFBAF v3.01). An exclusion of biotransformation resulted in a BCF of 18860 L/kg clearly indicating biotransformation of the test substance. Although, only the C18 unsaturated fatty acid monoester component of Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol and the C18 unsaturated fatty acid monoester component with sorbitan are within the training set defined by the log Pow and/or molecular weight, the results support the assumption of low bioaccumulation potential. Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation.

Toxicity

No effects up to the limit of water solubility occurred in the long-term toxicity test with Daphnia magna (OECD 211) with the read-across substances sorbitan stearate (CAS 1338-41-6) and Sorbitan, (Z)-9-octadecenoate (2:3) (CAS 8007-43-0). Moreover, Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol 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 Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol is not considered to meet the T-criterion.