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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, C8-10, octyl ester (CAS 91031-98-0) 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, C8-10, octyl esters (CAS 91031-98-0) is considered to be readily biodegradable according to OECD criteria (89% in 28 days. This assumption is based on data for the suitable read across substance octyl octanoate (CAS 2306-88-9). Thus, the test substance does not meet the screening criterion for persistence and it is not considered to be P or vP.

Bioaccumulation

Due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis of the test substance, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and the free alcohol. From literature it is well known, that these hydrolysis products will be metabolised and excreted in fish effectively (e.g., Heymann 1980, Lech & Bend 1980, Lech & Melancon 1980, Murphy & Lutenske 1990). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of Fatty acids, C8-10, octyl esters (CAS 91031-98-0). Thus the substance is not considered to be B or vB.

Toxicity

Long-term toxicity testing with Daphnia magna resulted in a NOEC of ≥ 100 mg/L for the read-across substance isopropyl myristate (CAS No. 110-27-0, OECD 211). Moreover, Fatty acids, C8-10, octyl esters 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 Fatty acids, C8-10, octyl esters (CAS 91031-98-0) is not considered to meet the T criterion.