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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 PBT Assessment for Fatty acids, C16-18, 2-octyldodecyl esters (CAS 96690-38-9) 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, C16-18, 2-octyldodecyl esters (CAS 96690-38-9) is readily biodegradable in one study according to OECD 301B (68.1 - 71.1% (CO2 evolution) after 28 d). Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.

Bioaccumulation

Fatty acids, C16-18, 2-octyldodecyl esters (CAS 96690-38-9) has a log Kow of > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. But due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis of the LCAE category members, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and the free alcohol. From literature it is well known, that these hydrolysis products will be metabolized and excreted in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990; Sand et al., 1973). This is supported by low calculated BCF values of 0.89 - 14.07 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the LCAE Category members. Thus, taking all information into account, the test substance is not considered to be B or vB.

Toxicity

Long-term toxicity testing with aquatic algae resulted in no effects on growth of algae. All available short-term toxicity data did not result in any toxicity up to the water solubility limit as well. Moreover, Fatty acids, C16-18, 2-octyldodecyl esters (CAS 96690-38-9) 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 the test substance is not considered to meet the T criterion.

Conclusion

In conclusion the substance is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.