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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, 2008) 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 the absence of persistence (P) is the potential of a substance for ready biodegradability. Methyl hexanoate (CAS No. 106-70-7) is readily biodegradable (78% biodegradation in 28 days, data from a structurally related analogue (methyl laurate (CAS No. 111-82-0) in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5). Therefore, it is not expected to be persistent in the environment and it does not meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) Assessment:

According to the Guidance on information requirements and chemical safety assessment, Chapter R.11 (ECHA, 2008) substances with log Kow values ≤ 4.5 are not considered B or vB (log Pow of methyl hexanoate = 2.34). Based on the above information, methyl hexanoate does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.

 

Toxicity (T) Assessment:

The chronic no-observed effect concentration (NOEC value) reported in the test conducted with algae is higher than 0.01 mg/L (other data not presently available). Further, the substance is neither 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, methyl hexanoate does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.

         

In conclusion, methyl hexanoate (CAS No. 106-70-7) is considered not to be PBT or vPvB.