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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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1,3-dioxolane-2-propanoic acid, 2,4-dimethyl-2,2'-(1,4-butanediyl)ester (DPDBE)
Type of composition:
boundary composition of the substance
State / form:
Reference substance:
1,3-dioxolane-2-propanoic acid, 2,4-dimethyl-2,2'-(1,4-butanediyl)ester (DPDBE)
PBT status:
the substance is not PBT / vPvB

The PBT Assessment for the substance is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT/ vPvB assessment (ECHA, 2014).


The substance is not considered as readily biodegradable. After 28 days it biodegraded by 43.43 % and thus it did not pass the level of 60 % CO2 evolution in order to be considered as readily biodegradable. In addition, the substance is expected to be hydrolytically stable at pH 7 suggesting a half life time more than a year. On the contrary, at 50 °C after 5 days, at pH 4 and pH 9 the substance hydrolyses by 96 % and 98 % respectively and has a half time of 12 days (at 25 °C). Thus, the test substance meets the criteria for persistence and it is considered to be P.


The uptake of an organic substance is driven by its hydrophobicity. For organic substances with a Log Kow value below 4.5 it is assumed that the affinity for the lipids of an organism is insufficient to exceed the B criterion, i.e. a BCF value of 2000 (based on wet weight of the organism, which refers to fish in most cases) (Chapter R.11, version 2.0, November 2014). The substance has a LogKow of 1.9 and a predicted BCF value of 8.22 l/kg. It is, therefore, not expected to bioaccumulate based on both LogPow and BCF values which are lower than the threshold for classification as B or vB.


Studies on the aquatic organisms suggest that the substance could cause acute toxic effects on fish, algae or microorganisms. Acute toxic effects on fish occured in much lower concentrations than the ones occurred on daphnia and algae. No long-term toxicity studies are available. The substance is however not classified for carcinogenicity, mutagenicity, reproductive toxicity or chronic toxicity and is thus not considered as T.

The substance is considered as Persistent (P) but not Toxic (T) nor Bioaccumulative (B). Since it meets only one criterion and not all the three criteria, the substance is not considered as PBT.