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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 is readily biodegradable with a log Kow at 5.09 (analogue), therefore does not meet the criterion for persistence (P) but met the screening criterion for bioaccumulation (B). However, as the substance is readily biodegradable, the substance will already be biodegraded in the Sewage Treatment Plant (STP) prior to dispersion into the environment, and potentially bioaccumulate. In addition to the metabolism by bacteria, the substance is metabolised by higher vertebrates (liver activity). Therefore, no exposure of aquatic and terrestrial organisms are expected. For the T criterion, only acute studies were available showing no toxic effects up to the attainable limit of solubility for the three trophic levels: fish, aquatic invertebrates and algae. The minimum attainable test concentration was 0.51 mg/L, corresponding to a loading rate of 100 mg/L, in the fish acute study. Therefore, acute aquatic L(E)C50 values are greater than 0.1 mg/L. This data do not allow a direct comparison to definitive criteria but nevertheless indicate that the substance is presumably not T (screening assessment). Regarding human health endpoints, the substance does not meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A, 1B or 2) and there is no evidence of chronic toxicity, as the substance does not meet the criteria for classification as STOT RE (category 1 or 2) according to regulation EC No1272/2008. Therefore, the substance does not fulfill the T criteria.

In conclusion, the substance could not be considered as a PBT or vPvB substance.

Likely routes of exposure:

None