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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, C16-18, 2-hydroxyethyl ester, (CAS 97281-23-7) 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

fatty acids, C16-18, 2-hydroxyethyl ester, (CAS 97281-23-7) is readily biodegradable. This was shown in one study according to OECD 301B (95% after 28 d) with the read-across substance fatty acids, C16-C18 ester, with diethylene glycol (CAS 85116-97-8). 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. 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 NOEC (21 d) of ≥ 0.02 mg/L for the read-across substance butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) (OECD 211). The read-across is justified in detail in the read-across justification in section 13. Moreover, fatty acids, C16-18, 2-hydroxyethyl ester, (CAS 97281-23-7) is not classified according to Regulation (EC) No. 1272/2008 (7th 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.