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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 registered substance is hydrolytically stable at any pH (from 2 to 12) and not readily biodegradable.Therefore, in the absence of valid simulation studies, the registered substance can be considered as potentially persistent (potential P) or potentially very persistent (potential vP) in the environment.

According to a bioaccumulation study (OECD Guideline 305) performed for a Japanese notification, the BCF values for Cyprinus carpio were comprised between 46 and 60. Therefore, the registered substance is not bioaccumulable or very bioaccumulable.

One long-term aquatic toxicity data is available on algae with an ErC10 value greater than 0.01 mg/L (at 1.38 mg/L). In addition, short-term aquatic toxicity data are available on the three aquatic trophic levels (algae, daphnia, fish) with E(L)C50 values greater than 0.1 mg/L (lowest value at 1.1 mg/L). The registered substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 and no other evidence of chronic toxicity was observed, as identified by the classification specific target organ toxicity after repeated exposure (STOT RE Category 1 or 2) according to Regulation EC No 1272/2008. The registered substance is therefore not toxic.

In conclusion, the registered substance does not fulfill any of the PBT or vPvB criteria.