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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:

According to Regulation (EC) No. 1907/2006, a substance must fulfil all three criteria for persistence, bioaccumulation and toxicity to be considered as PBT, as listed in part 1 of Annex XIII, and it must fulfil the criteria for persistence and bioaccumulation stated in part 2 of Annex XIII to be considered vPvB. 

Data for the definitive conclusion on the PBT or vPvB properties according to the criteria set in Regulation (EC) No. 1907/2006, Annex XIII, parts 1 and 2, are not available for all three criteria. Thus, the screening criteria given in the ‘Guidance on information requirements and chemical safety assessment - Chapter R.11: PBT assessment’ (ECHA, 2012) are used as surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB criteria.

Persistence (P) Assessment:

A valid screening criterion to evaluate persistence (P) is the potential of a substance for ready biodegradability. In the ready biodegradation test conducted with 2-methyl-N-(4-sulfamoylphenyl) prop-2-enamide (SPM-N), no significant biodegradation of the substance was observed (1% biodegradation in 28 days). In the absence of other degradation data, the Persistent (P) or very Persistent (vP) criteria cannot be excluded for this substance.

Bioaccumulation (B) Assessment:

In the absence of bioaccumulation data, the log Kow value of SPM-N is used as surrogate indicator of the bioaccumulation potential of the substance. According to the Guidance on information requirements and chemical safety assessment, Chapter R.11 (ECHA, 2012), substances with log Pow values ≤ 4.5 can be considered not to be Bioaccumulative (B) or very Bioaccumulative (vB). Since the log Pow of SPM-N is 0.6, the B and vB criteria can be excluded.

Toxicity (T) Assessment:

No adverse effects were reported in the acute tests conducted with SPM-N on fish, aquatic invertebrates and algae, with EC50 values > 29 mg/L for fish and aquatic invertebrates, and > 30 mg/L for algae. These values are well above the trigger values of 0.1 and 0.01 mg/L described in the 'Guidance on information requirements and chemical safety assessment, Chapter R.11' (ECHA, 2012) to consider a substance as T. Moreover, the substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC. Therefore, SPM-N does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.

In conclusion, SPM-N is considered not to be PBT or vPvB.