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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, C18 unsaturated, trimers, hydrogenated 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

Based on the low biodegradation rate in the ready biodegradation studies (< 15% in 28 days) Fatty acids, C18 unsaturated, trimers, hydrogenated can be considered to be potentially fulfilling the criteria for Persistence (P) and (vP).

Bioaccumulation

AsFatty acids, C18 unsaturated, trimers, hydrogenatedhas low water solubility (0.001 mg/L), the aqueous concentration will be very low and consequently, exposure to the aquatic environment would be extremely low, if at all. This automatically reduces, if not eliminates, the uptake of the chemical through the aquatic environment. Additionally,Fatty acids, C18 unsaturated, trimers, hydrogenatedhas a low potential to cross biological membranes due to the large molecular size of its constituents. In case of uptake and absorption, rapid metabolism of fatty acids occurs.This is supported by the low calculated BCF value 0.893 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Please refer to Section 5.3 of the technical dossier for a detailed overview on bioaccumulation.Hence,the substancedoes not pose a risk to organisms in regard to bioaccumulation/biomagnification and is not considered to be B or vB.

Toxicity

No effects on reproduction occurred in the long-term toxicity test with Brachydanio rerio (ISO/DIS 10229-1) up to the limit of water solubility of the test substances with the read-across substance Fatty acids, C18-unsatd., dimers, hydrogenated (CAS No. 68783-41-5). Moreover, Fatty acids, C18 unsaturated, trimers, hydrogenatedis 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, C18 unsaturated, trimers, hydrogenatedis not considered to meet the T criterion.