Registration Dossier
Registration Dossier
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EC number: 700-637-0 | CAS number: 902272-78-0
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- 1,3-Dioxolane-2-propanoic acid, 4-(hydroxymethyl)-2-methyl-, ethyl ester (DPHME)
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- 1,3-Dioxolane-2-propanoic acid, 4-(hydroxymethyl)-2-methyl-, ethyl ester (DPHME)
- Reference substance:
- 1,3-Dioxolane-2-propanoic acid, 4-(hydroxymethyl)-2-methyl-, ethyl ester (DPHME)
- Name:
- 1,3-Dioxolane-2-propanoic acid, 4-(hydroxymethyl)-2-methyl-, ethyl ester (DPHME)
- Type of composition:
- boundary composition of the substance
- State / form:
- liquid
- Reference substance:
- 1,3-Dioxolane-2-propanoic acid, 4-(hydroxymethyl)-2-methyl-, ethyl ester (DPHME)
- PBT status:
- the substance is not PBT / vPvB
- Justification:
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).
Persistence
The substance is not considered as readily biodegradable. After 28 days it biodegraded by 68.38 % but failed to meet the 10 -day window criterion. Based on the study report, since the substance passed the level of 60 % CO2 evolution, it can be considered as ultimately biodegradable. In addition, the substance is hydrolytically stable at pH 7 suggesting a half-life time more than a year (at 25 °C). On the contrary, 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.
Bioaccumulation
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 0.37 and a predicted BCF value of 1.41 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.
Toxicity
Studies on the aquatic organisms suggest that the substance has no toxic effects on fish, algae or microorganisms under the test conditions. Toxic effects occur after the exposure of daphnia to the substance and the EC50 is as high as 386 mg/l. The substance is also not classified for carcinogenicity, mutagenicity, reproductive toxicity or chronic toxicity.
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.
Referenceopen allclose all
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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