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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 (even numbered) and C18-unsatd., branched and linear, di and triesters with trimethylolpropane (EC-No. 931-531-4) 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 (even numbered) and C18-unsatd., branched and linear, di and triesters with trimethylolpropane (EC-No. 931-531-4) is considered to be readily biodegradable. This assumption is based on a study conducted according to OECD 301F (86% (O2 consumption) 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

The bioaccumulation potential of Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di and triesters with trimethylolpropane (EC-No. 931-531-4) is expected to be low. This assumption is based on a low bioavailability of the substance due to its ready biodegradability and low water solubility. Furthermore the substance is rapidly metabolised and excreted by organisms and thus an accumulation is not expected. This is supported by calculated low BCF values (0.89 L/kg; Arnot-Gobas estimate, upper trophic). Thus the substance is not considered to be B or vB.

Toxicity

Fatty acids, C16-18 (even numbered) and C18-unsatd., branched and linear, di and triesters with trimethylolpropane (EC-No. 931-531-4) is considered to be not toxic. The assessment is based on a read across to the structurally similar TMP group member Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8). In a study investigating the long-term toxicity of Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane to Daphnia magna a NOELR (21 d) ≥ 0.11 g/L was recorded. The substance affected neither the survival rate nor the reproduction rate of Daphnia magna Furthermore the substance 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 substance is considered to be not T.

 

Conclusion

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