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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
Justification:

The PBT Assessment for2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoateis based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).

Persistence

One study according to OECD 301B resulted in 6% (CO2 evolution) degradation after 60 d. Thus, according to the definite criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 the substance is considered to be very persistent (vP).

Bioaccumulation

2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoateis characterized by a low water solubility (< 0.05 mg/L), high log Kow (> 10) and high molecular weights (697.04 g/mol). Based on the physico/chemical properties such as low water solubility and high potential for adsorption a reduced availability in water is expected. The high molecular weight of the substance significantly reduces the absorption due to sterical hindrance to cross biological membranes. It can be concluded that the log Kow indicating a potential for bioaccumulation, overestimates the true bioaccumulation potential of the substance. BCF/BAF values estimated by QSAR (BCFBAF v3.01) also indicate that the substance will not be bioaccumulative (all well below 2000 L/kg). Taking all these information into account, it can be concluded that bioaccumulation of2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoateis unlikely to occur.

Toxicity

A long-term toxicity study according to OECD 211 is ongoing. The toxicity assessment will be re-evaluated and the dossier updated when the additional study on aquatic invertebrates is available. Moreover,2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoateis not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (2nd 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.

Conclusion

In conclusion the substance is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.