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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The test substance Dantocol DHE meets the P criterion but does not meet the B or T criteria based on the following evidence:

Persistence: The evidence indicates the test substance is Persistent. A maximum of 17% biodegradation was observed after 28 days in ready biodegradation studies. An inherent biodegradation study demonstrated no potential for biodegradation. The hydrolysis half-life was calculated at >1 year.

Bioaccumulation: ECHA guidance states that where the Log Kow of a test substance is ≤3, the requirement for bioaccumulation testing can be waived as the test substance has a low potential to bioaccumlate. The Log Kow of the test substance was measured as -1.32 in a validated, acceptable GLP study and therefore the potential for bioaccumulation in aquatic organisms is considered low. The test substance does not meet the B criterion.

Toxicity: The lowest toxicity value for the test substance is 100 mg/L, which is several orders of magnitude greater than the T criterion of <0.01 mg/L. The test substance is not classified as carcinogenic (category 1A or 1B), germ mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2). The test substance is not classified for chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1 or category 2 according to Regulation (EC) No 1272/2008.