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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

The PBT Assessment for Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8)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 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) is considered to be readily biodegradable. This assumption is based on a study conducted according to OECD 301B (86.6% (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
The bioaccumulation potential of Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) 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/BAF 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 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) is considered to be not toxic. In a study on the long-term toxicity of the substance to Daphnia magna a NOELR (21d) ≥ 0.11 g/L (nominal; WAF) was recorded. 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.