Registration Dossier

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 tetradecyl laurate is based on tetradecyl myristate (CAS3234-85-3) and compliant with the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012)

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Persistence

As most if not all mono-esters of a fatty acid and a fatty alcohol, tetradecyl laurate can be considered as readily biodegradable. This dossier includes a study performed with its analogue, tetradecyl myristate (CAS 3234-85-3) according to OECD 301C (67% (BOD) after 28 d). Therefore it can be concluded that tetradecyl laurate does not meet the screening criterion for persistency and it is not considered to be P or vP.

Bioaccumulation

As a consequence of the long carbon chains of both the acid as the alcohol, tetradecyl laurate has a relatively high log Kow of > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. However, due to the extremely low water solubility combined with a 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).

Thus, tetradecyl laurate is not considered to be B or vB.

Toxicity

All available short-term toxicity data with the analogue tetradecyl myristate (CAS3234-85-3) did not result in any toxicity up to the water solubility limit tested as water accomodated fraction of a loading rate (LR) of 100 mg/L. Long-term toxicity testing with Daphnia magna resulted in a NOEC ≥ 10 mg/L, respectively. Moreover, various LCAE category members registered are 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 tetradecyl laurate is not considered to meet the T criterion.

Conclusion

In conclusion, tetradecyl laurate does not meet the criteria for classification as PBT or vPvB based on the available data.