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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Type of composition:
legal entity composition of the substance
State / form:
Related composition:
Reference substance:
PBT status:
the substance is not PBT / vPvB

The test substance is deemed not PBT or vPvB. This conclusion was drawn based on the screening criteria for P, B and T. Screening criteria were used due to lack of other data, as the registration regards the tonnage band 10 -100 tpa.

Not P - not vP

The conclusion on not P or vP is based on the fact that the substance is readily biodegradable, fulfilling the 10-day window.

Not B - not vB

The conclusion not B or vB rests on the fact that the measured log Kow = 2.00, hence below the cut-off value 4.5. Moreover, QSAR predictions using EpiSuite confirm that the BCF is below 2000, with the estimated BCF being 9.696 L/kg.

Not T

The test substance was found to be not T, because the substance is (i) not CMR (not classified for H350, H340, H372, H373, H350i, H360 or H361), (ii) there is no other evidence for chronic toxicity and (iii) the EC50 values are well above 0.1 mg/L for all 3 trophic levels and the available chronic data for algae is >0.01 mg/L. Given that also the P and B assessment resulted in the conclusion that the substance is not P, not vP, not B nor vB, no further assessment on T is required and no additional studies need to be performed.