Registration Dossier
Registration Dossier
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EC number: 204-649-2 | CAS number: 123-76-2
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- Levulinic acid
- Type of composition:
- boundary composition of the substance
- State / form:
- solid: bulk
- Reference substance:
- Levulinic acid
- Name:
- Levulinic acid
- Type of composition:
- legal entity composition of the substance
- State / form:
- solid: bulk
- Reference substance:
- Levulinic acid
- 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 readily biodegradable; it presents a biodegradation rate > 60 %, meeting the 10-day window in the 28-day test.. Thus, the test substance does not meet the criteria for persistence and it is not considered to be P or vP.
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 - 0.498. Thus the substance is not considered to be B or vB.
Toxicity
Studies on the acute oral toxicity of the substance showed that it is expected to be toxic after an acute exposure via the oral route. Its reproductive/developmental toxicity and toxicity after repeated dose is not yet evaluated since a testing proposal is submitted for both endpoints. The substance is not classified for mutagenicity. Based on the available data the substance is not considered to have Toxic properties.
The substance is not considered as persistent (P), bioaccumulative (B) nor toxic (T), and it 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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