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PBT assessment

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PBT assessment: overall result

Reference
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)

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