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PBT assessment

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PBT assessment: overall result

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

The PBT assessment of Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), estersis based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

 

Persistence

Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters is readily biodegradable in one study according to OECD 301B (89.9% 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, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters has an estimated log Kow of > 10.0 (QSAR models VEGA and EPI Suite), which may indicate a potential for bioaccumulation. However, a significant uptake and bioaccumulation of the substance in aquatic organisms is not expected based on the very low water solubility (< 6.57 µg/L at 20 °C, pH 6.3, OECD 105), rapid biodegradation and metabolization via enzymatic hydrolysis into free fatty acids and alcohols. It is well known from literature that the hydrolysis products will be effectively metabolized and excreted by fish (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990; Sand et al., 1973). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance. Overall, the substance is not considered to be B or vB based on the available data.

Toxicity

Neither long-term nor short-term toxicity tests resulted in any toxic effects to aquatic organisms up to the limit of water solubility (< 6.57 µg/L at 20 °C, pH 6.3, OECD 105) of Fatty acids, C16, C18 and C18-unsaturated, C12-15 alcohol (linear and branched), esters. Furthermore, the substance is not classified according to the consolidated Regulation (EC) No 1272/2008 and further amendments (ATPs). Therefore, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and it is concluded that the substance is not T.

 

In conclusion, the substance is not PBT/vPvB.

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