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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 Hexadecyl palmitate (CAS 540-10-3) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment”.

 

Persistence

Hexadecyl palmitate (CAS 540-10-3) is readily biodegradable according to the OECD criteria in a study according to OECD 301 C (75.3% BOD after 28 d). Therefore, the substance does not meet the screening criterion for persistence and is not rated P or vP.

 

Bioaccumulation

Hexadecyl palmitate (CAS 540-10-3) has an estimated log Kow of > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. However, a significant uptake and bioaccumulation of the substance in aquatic organisms is not expected based on the low water solubility, rapid biodegradation and metabolization via enzymatic hydrolysis, which produces free fatty acids and alcohols.

It is well known from literature that in fish, these hydrolysis products will be effectively metabolized and excreted (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 dw (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance. Overall, taking all information into account, the substance is not considered to be B or vB.

 

Toxicity

Neither long-term test with aquatic algae and aquatic invertebrates nor short-term toxicity tests with representative species from three trophic levels resulted in any toxic effects of hexadecyl palmitate (CAS 540-10-3) up to the limit of water solubility. Furthermore, the substance is not classified according to Regulation (EC) No 1272/2008. 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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