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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:

Sucrose acetate isobutyrate (SAIB) demonstrated greater than 60% biodegradation in an enhanced ready biodegradation study based upon CO2 evolution (ultimate biodegradation) which meets the screening criteria to eliminate concerns for persistence (P and vP).

A lack of B or vB potential is demonstrated by a weight of evidence from experimental mammalian toxicokinetic data and QSAR modeling of BCF/BAF for fish where biotransformation is taken into account.

SAIB also shows a lack of toxicity (T) based upon acute and long-term aquatic toxicity studies demonstrating a lack of toxicity at the limit of water solubility, and long-term NOEC values for daphnia and algae that are > 0.01 mg/L, as well as human health toxicological studies.