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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:

Following the criteria provided by ECHA for REACH, the substance is considered not to be PBT/ vPvB as it reached/exceeded the pass level of 60% ThOD in three enhanced ready biodegradability tests, has a measured log Pow of less than 4.5 and BCF estimates significantly lower than 2000, and the E(L)C50 values for fish, Daphnia and algae are >0.1mg/L. Furthermore, there is no evidence of chronic toxicity, STOT RE or CMR effects.

 

In addition, chemical specific analysis confirmed that there was no parent remaining at the end of a prolonged 301F test indicating complete primary biodegradation of the registered substance. Chemical specific analysis also included two expected primary biodegradation metabolites, the corresponding amide and corresponding acid of the parent substance. No significant evolution of the acid metabolite analytical target was observed, while the amide metabolite analytical target increased slightly up to days 14/21 and then declined to be non-detectable by the end of the test. These results coupled with the high BOD at the end of the test (73%, day 60) indicate that any metabolites formed following primary degradation are transient and not persistent. Further any transient metabolites have a low likelihood of bioaccumulation potential given biodegradation pathways tend to lead to more polar metabolites and the parent substance itself is not B. This is supported by CATALOGIC predictions. Thus, the registrant considers that there is no need to identify degradation products in order to assess their potential PBT/vPvB properties.