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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

The PBT Assessment for 2-octyldodecyl myristate (CAS 22766-83-2) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2014).

Persistence Assessment

2-octyldodecyl myristate is readily biodegradable. This was shown in one study according to OECD 301B (68.1 - 71.7% after 28 d) with the read-across substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3). The read-across is justified in detail in the read-across justification in section 13. Thus, the substance does not meet the screening criterion for persistency and it is not considered to be P or vP.

Bioaccumulation Assessment

Bioaccumulation is not a standard requirement according to Regulation (EC) No. 1907/2006, Annex VII-VIII. However, the substance is considered to be readily biodegradable and expected to be rapidly metabolised. This is further supported by reliable QSAR data with a BCF clearly below 2000 L/kg. Thus, bioaccumulation and secondary poisoning are very unlikely. The substance is not considered to be B or vB.

Toxicity Assessment

Long-term toxicity testing with Daphnia magna resulted in a NOELR (21 d) of ≥ 10 mg/L for the read-across substance Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0) (OECD 211). The read-across is justified in detail in the read-across justification in section 13. Moreover, 2-octyldodecyl myristate is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (4th ATP). Thus, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.