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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 of fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) is 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, C14-22, C16-24-alkyl esters (CAS 92797-30-3) is readily biodegradable according to the OECD criteria (68.1 – 71.7% CO2 within 29 d, OECD 301 B). Therefore, the substance does not meet the screening criterion for persistence and is not rated P or vP.

 

Bioaccumulation

Fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) has an estimated log Kow of > 10.0 (KOWWIN v1.68). A significant uptake and bioaccumulation of the substance in aquatic organisms is not expected based on the very low water solubility (<2.5 µg/L), 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). Overall, the substance is not considered to be B or vB.

 

Toxicity

Neither long-term nor short-term toxicity tests resulted in any toxic effects to aquatic organisms up to the limit of water solubility of fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3). Furthermore, the substance is not classified according to the consolidated Regulation (EC) No 1272/2008 (dated: 01.01.2017) 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.

References are provided in Annex 1 of the Chemical Safety Report.