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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:

The hydrolysis study was waived due to the very poor water solubility of the test item. Based on lacking biodegradability as observed in an inherent biodegradability study and an anaerobic biodegradability study, for the time being the substance shall be assessed to be persistent. Being in line with ECHA guidance documents, screening assignment is vP (P), as the B or vB criterion is not fulfilled no further testing shall not be considered in context with the PBT /vPvB assessment (at least as long as not required for more in-depth PBT discussions).

Bioaccumulation:

It can be concluded that the substance does not meet criteria for B / vB substance. The bioaccumulation study in fish was performed via dietary exposure route. The result obtained shows that the biomagnification factor is far below 1 and the half-life for elimination of BMDBM during depuration phase is 3.8 days. Following the ECHA Endpoint specific guidance R.7c, the BCF value of 1807 L/kg was calculated on the basis of the experimental data obtained in the bioaccumulation study. The BCF value is below the cut-off value of 2000 for B/vB. These results indicate that risk for bioaccumulation and biomagnification in fish is low.

Toxicity:

The substance has no CMR, R48, or STOT RE toxicity classification. Acute aquatic toxicity studies conducted up to the level of maximum water solubility revealed no detrimental effects. Currently available data make it appear as unlikely that the substance exhibits long-term toxic effects in the (aquatic) environment. Based on these grounds the screening assignment is "not T".