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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:

P criteria:

– the half-life in marine water is higher than 60 days, or

– the half-life in fresh- or estuarine water is higher than 40 days, or

– the half-life in marine sediment is higher than 180 days, or

– the half-life in fresh- or estuarine water sediment is higher than 120 days, or

– the half-life in soil is higher than 120 days

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 studies in two comparable, structural analogues, which showed 7% and 5% degradation after 28 days.

Based on this, the P criteria is considered to be met, but a full assessment of vP cannot be made.

Bioaccumulation Assessment:

B criteria: BCF > 2000.

vB criteria: BCF >5000

No experimental bioaccumulation data is available to compare against the criteria for B or vB. No experimental study is considered feasible to conduct based on the substance properties.

Based on the initial screening criteria for B/vB (where log Kow >4.5 indicates bioaccumulation) the substance could be considered to meet either the B or vB criteria based on the experimental log Kow of >6.5. However, further assessment of the substance properties (molecular weight, log Kow properties) indicate that bioaccumulation may not be significant for the substance and that the B/vB criteria may not be met (refer to discussion of bioaccumulation section for full details).

Predicted BCF values for individual components were significantly below 2000, indicating that the B and vB criteria are not met.

Therefore, it may provisionally be considered that the substance does not meet the B or vB criteria.

Toxicity Assessment:

T criteria:

– the long-term no-observed effect concentration (NOEC) for marine or freshwater organisms is less than 0.01 mg/l, or

– the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2) or toxic for reproduction (category 1, 2, or 3) according to Directive 67/548/EEC or as carcinogenic (category 1A, 1B or 2), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008, or

– there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure (STOT-RE category 1 or 2) according to Regulation EC No 1272/2008.

No long-term fish or daphnia study is available to compare against the criteria. However, although the algal test is a short-term test it provides both acute and chronic endpoints. Therefore, if assessed as a chronic/long-term endpoint the T criteria is not met as the NOEC was established as 10 mg/l.

In addition, 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 greater than 0.1 mg/l (and above the level of water solubility of the substance). Therefore, it is presumed that the T criteria is not met.

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

The substance is not classified for chronic toxicity (R48) or for STOT RE based on the results of a 90-day repeated dose toxicity study. No other evidence of chronic toxicity has been noted in any other long-term studies, such as a pre-natal developmental study.

Therefore the T criteria is not met.