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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:

Comparison with the Criteria of Annex XIII. An assessment of the PBT/vPvB status of the test substance has been made using all available data.

Persistence Assessment.

A modified MITI test (OECD 301C; see Section 5.2.1) showed that the test substance is not readily biodegradable; the test substance is therefore identified as being potentially persistent.

Bioaccumulation Assessment

No studies to assess bioaccumulation in aquatic species have been conducted. The low Log Kow value (<4.5) indicates that the test material is unlikely to be bioaccumulative in aquatic systems, and as such is considered to have a low potential for bioaccumulation.

Toxicity assessment

The acute toxicity concentrations for all three trophic levels are much higher than the PBT screening criterion of <0.1 mg/L (no toxicity observed at limit of aqueous solubility). It can therefore be expected that the test substance is not potentially toxic towards aquatic organisms. In addition, data is not available indicating that the test substance is a CMR and there is no evidence that the test material is chronically toxic towards mammals. Therefore, based on the aquatic and mammalian toxicity data, the test substance is not assigned as being toxic.

The overall conclusions, based on the present available data, are that the (screening) criteria for PBT/vPvB, as outlined in Annex XIII of Directive 2006/121/EC, are not met and that further testing in the scope of the final PBT assessment is not considered to be required.