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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 2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate (CAS 15834-04-5) 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

2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate (CAS 15834-04-5) is readily biodegradable according to OECD criteria. Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.

Bioaccumulation

2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate (CAS 15834-04-5) has a log Kow of > 6 (KOWWIN v1.68) indicating a potential for bioaccumulation. But due to the low water solubility, rapid environmental biodegradation and metabolisation via enzymatic hydrolysis of the Polyol esters category members, 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 metabolized and excreted in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990; Sand et al., 1973). This is supported by a low calculated BCF value of 6.32 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the category members. Thus, taking all information into account, the test substance is not considered to be B or vB.

Toxicity

Long-term toxicity testing with read-across substances resulted in no effects up to the limit of water solubility. In addition, the test substance shows no acute toxicity on all three trophic levels (fish, aquatic invertebrates, algae) in the range of water solubility. The test substance is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (2nd ATP). Therefore, 2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate (CAS 15834-04-5) does not meet the T criterion set out in Annex XIII of Regulation (EC) No. 1907/2006.

A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.