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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The Isosorbide dioctanoate is considered a s readily biodegradable and so it is not persistent.

Since the log Kow < 4.5, the Isosorbide dioctanoate is not considered as potentially bioaccumulable. Moreover taking into account the results of the biodegradation study and the toxicokinetic study performed on a very similar substance, it is expected that this substance will be quickly metabolised by enzymatic systems.

On the basis of the toxicological and ecotoxicological profiles, which show no adverse effect in acute and long-term tests, the Isosorbide dioctanoate is not considered as toxic.

The substance is not persistent, not bioaccumulable and not toxic. So it is neither PBT, nor vPvB.