Registration Dossier
Registration Dossier
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EC number: 939-514-3 | CAS number: 1471312-26-1
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment forPropanoic acid, 2-hydroxy-, C12-13-branched-alkyl estersis based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).
Persistence
Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl estersis readily biodegradable in one study according to OECD 301F (82.2% (O2 consumption) after 28 d). Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.
Bioaccumulation
The bioaccumulation factor (BCF) of all components of the UVCB substance was estimated using a reliable QSAR model (BCFBAF v3.01; Müller, 2011). All components were in the applicability domain of the model indicating that the results are reliable and can be used to assess the bioaccumulation potential of Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters. The BCF was calculated to be in the range of 45.78 - 61.6 L/kg (upper trophic) using the model of Arnot-Gobas which includes biotransformation. Exclusion of biotransformation resulted in clearly higher BCF values of 4808 - 11080 L/kg. Thus, it can be concluded that the substance will be extensively metabolized (half-life of 0.1073 - 0.1478 d) which reduces the bioaccumulation potential significantly. In conclusion, Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters has a low potential for bioaccumulation and the highest calculated BCF of 61.6 L/kg is clearly below the trigger value of 2000 L/kg to be classified as bioaccumulative (B-criterion) in the PBT assessment. Thus, taking all information into account, the test substance is not considered to be B or vB.
Toxicity
One long-term toxicity study is available for Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters. A NOELR (21 d) of 0.11 mg/L resulted in an OECD 211 study with Daphnia magna. The effect concentration is above the trigger value of 0.01 mg/L set out in Annex XIII of Regulation (EC) No. 1907/2006. Furthermore, the substance is not classified for human health effects. Thus, 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.
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