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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:

P assessment

Biotic degradation observed was very low in an OECD 301B (ready biodegradability) study. Therefore, the substance, according to Guidance on information requirements and CSA R.11, can be considered P with some potential of being vP.

Study on abiotic degradation was technically not feasible for the very low solubility of the substance, which confirms the high potential to persist.

B assessment

Log Kow is higher than 4.5 for every component of the substance, according to calculated values coming from reliable QSAR model.

However, calculated BCF values for components are in the range 3.16 - 645 L/Kg, clearly lower than the threshold for B-criterion of 2000 L/Kg. Therefore, the substance does not fullfill the B-criterion.

T assessment

The substance is not classified for any of the toxicological properties listed in Annex XIII of the REACH legislation.

No long-term studies on aquatic toxicity are available, but acute LC50 is >100 mg/L for all trophic levels.

According to these data, the substance can be considered not fulfilling the T-criterion.