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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 does not meet the criteria to be classed as a PBT or vPvB substance, based on both screening criteria and Annex XIII criteria.

Persistence Assessment:

No relevant half-life data is available from hydrolysis or simulation studies, Therefore the assessment of the P/vP criteria was based on the screening criteria of ready biodegradation.

The substance is not readily biodegradable based on the results of a MITI biodegradation study, where the substance attained 0% degradation after 28 days.

Based on this screening result, the P criteria and possibly vP criteria is considered to be met.

Bioaccumulation Assessment:

The results of a bioaccumulation study in carp showed the substance to have BCF values <2000 and therefore the criteria for B/vB is not met.

This is supported by an assessment of bioaccumulation that has been made using the screening criteria (log Kow).

The octanol/water partition coefficient of the substance has been experimentally determined to be log Kow (Pow) 2.78, indicating a low potential for bioaccumulation, and therefore the substance does not meet the screening criteria for B or vB.

Toxicity Assessment:

No long-term fish or daphnia studies are available to compare against the criteria.However, based on screening criteria for T, if short-term aquatic toxicity testing results in EC50 or LC50 values greater than 0.1 mg/l, the T criteria is presumed not to be met. Acute toxicity testing in fish, daphnia and algae all resulted in EC50 and LC50 values of greater than 0.1 mg/l (0.1 mg/l was the highest attainable test concentration).

The substance is not classified as carcinogenic, mutagenic or toxic for reproduction based on available study data.

The substance is not classified for chronic toxicity (either R48 or STOT RE) based on available study data.

The substance does not therefore meet the 'T' criteria.