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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:

Data for the definitive conclusion on the PBT or vPvB properties of Ziram (CAS No. 137-30-4) are available, except for those regarding the Bioaccumulation (B) criterion. Thus, the screening criteria given in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT assessment” (ECHA, 2008) are used as surrogate information to decide whether this substance meets the B criterion and further on, may potentially fulfil the PBT or vPvB criteria.

Persistence (P):

According to the criteria stated in Regulation (EC) 1907/2006, Annex XIII, persistence can be determined through the evaluation of the dissipation half-lives of a substance in different environmental compartments. Experimental data on the biodegradation of Ziram in water, sediment and soil are available. Hydrolysis (half-lives of 10.4 minutes, 17.67 hours and 6.31 days at pH 5, 7 and 9) and photolysis (half-life < 10 hours) contribute significantly to the degradation of this substance in water. Ziram is also rapidly degraded in water/sediment and soil systems, in which half-lives below 2 days were reported, respectively. Thus, the P criterion is not met for this substance.

Bioaccumulation (B):

Experimental data determining the Bio Concentration Factor (BCF) of Ziram in aquatic organisms are not available. Nevertheless, the log Kow of the substance is considered as a good surrogate for the evaluation of the B criterion. Based on its log Kow value, below 3, Ziram shows low potential for bioaccumulation. Therefore, this substance does not meet the B criterion.

Toxicity (T):

According to the criteria stated in Regulation (EC) 1907/2006, Annex XIII, the toxicity of a certain substance can be assessed based on the available toxicity data on aquatic organisms and mammals. The long-term study performed testing the chronic effects of Ziram on fish species resulted in a NOEC value of 78 µg a.i./L (above 0.01 mg/L). However, this substance is classified as Xn, R48, Harmful, and therefore it can be considered as T