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PBT assessment

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PBT assessment: overall result

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Name:
Levulinic acid
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Name:
Levulinic acid
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
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.