Registration Dossier
Registration Dossier
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EC number: 208-728-2 | CAS number: 539-88-8
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Ethyl levulinate
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Reference substance:
- Ethyl levulinate
- 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, 2017).
Persistence
The substance is readily biodegradable based on the results of a ready biodegradation test; it biodegraded by 72 % within 28 days. Thus, the test substance does not meet the screening criterion for persistence and it is not considered to be P or vP.
Bioaccumulation
The substance is not expected to biaccumulate based on the physicochemical properties of the substance and the predicted BCF value. 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 3.0, June 2017). The substance has a LogKow of 0.324. Furthemore, the predicted BCF of the substance (3.162 l/kg) suggest that the BCF of the substance is much lower than BCF threshold value for bioaccumulation (2000 l/kg). Thus the substance is not considered to be B or vB.
Toxicity
No long term toxicity data is available for the aquatic organisms, while during the short term toxicity studies no hazard is identified. Studies on the acute oral toxicity of the substance showed that it is not expected to be toxic after an acute exposure. No data is yet available for the toxic potential of the substance to humans after chronic exposure. The substance is not classified for carcinogenicity or mutagenicity. Since, chronic toxicity data is not yet available, no conclusion can be reached based on available information.
Considering that the substance does not meet the criteria for Persistency (P) or Bioaccumulation (B), even if no conclusion can be reached for the Toxicity (T), it is not considered as PBT as it does not meet the other two criteria (P, B)
Reference
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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