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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 substance showed a mean of 42% degradation after 28 days in a 302C test and was therefore considered to be inherently biodegradable. Log Kow was found to be 5.77 anb used to estimate the BCF by EPIWIN: BCF estimation is 10 showing that the substance has a low potential for bioaccumulation. No long-term toxicity study are available. However, the EC10 (growth rate) for algae (72h) was found to be 0.049 mg/L. Based on the effects observed in the reproduction/developmental toxicity screening test at the highest dose level of 1000 mg/kg/day the substance is currently as Reprotox. Cat 2 according to CLP Regulation (EC) No 1272/2008. Therefore, until confirmation from higher tier studies, T properties cannot be excluded.

Consequently the substance is not fulfilling the P or vP, B or vB criterion according to Annex XIII of the REACH regulation. The T criterion needs to be clarified. The substance is not a PBT or vPvB substance according to the REACH regulation.