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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:

PERSISTENCE ASSESSMENT

The registration substance is not readily biodegradable (IUCLID Chapter 5.2.1). Therefore the 'vP' criteria of the vPvB / PBT Assessment is fulfilled.

 

BIOACCUMULATION ASSESSMENT

The registration substance has a measured Log Kow of 1.6 (see IUCLID Chapter 4.7). Therefore the 'B' criteria for the vPvB / PBT Assessment is not fulfilled.

In addition BCF values have been calculated with US EPA software EPWWIN v4.1, BCFBAF v3.01. All calculated BCF values are below 35 L/kg ww.

Based on the measured Log Kow the Exposure modelling program EUSES 2.1 estimates a BCF fish of 4.57 L/kg wwt and a BCF worm of 1.32 L/kg wwt .

 

TOXICITY ASSESSMENT

In acute toxicity tests for the aquatic compartment on daphnia, algae, fish and microorganism no hazard was identified below 0.01 mg/l (see IUCLID Chapter 6.1). Fish is the most sensitive species with NOEC=6.25 mg/L and LC50=14.5 mg/l. In addition no human health hazard in regard to carcinogenicity, mutagenicity, toxicity to reproduction, chronic toxicity, germ cell mutagenicity or specific target organ toxicity after repeated exposure was identified.

Therefore the 'T' criteria of the PBT / vPvB Assessment is not fulfilled.

 

CONCLUSION

In conclusion the registration substance is not PBT / vPvB.