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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 Propyleneglycol dioleate (CAS 105-62-4) 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

Propyleneglycol dioleate is readily biodegradablein. This was shown in one study according to OECD 310 (79.9% after 28 d) with the read-across substance propylene glycol diisostearate (CAS 68958-54-3). The read-across is justified in detail in the read-across justification in section 13. Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.

Bioaccumulation Assessment

Propyleneglycol dioleate has a log Kow of > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. But due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and the free glycol alcohol (e. g. ethylene glycol). From literature it is well known, that these hydrolysis products will be metabolized and excreted in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990). This is supported by a low calculated BCF value of 0.893 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Thus, taking all information into account, the test substance is not considered to be B or vB.

Toxicity Assessment

Long-term toxicity testing with Daphnia magna resulted in a NOEC 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, Propyleneglycol dioleate 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.