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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 persistence (P) is the potential of a substance for ready biodegradability. Fatty acids, C12-16 (even numbered) and C18-unsatd., methyl esters (CAS No. 1234694-02-0) is readily biodegradable (78%, 90.4% and 75% biodegradation in 28 days). 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:

An evaluation of the bioaccumulation potential of Fatty acids, C12-16 (even numbered) and C18-unsatd., methyl esters (CAS No. 1234694-02-0) is presented in chapter 5.3 indicating that bioaccumulation is expected to be low. Due to its ready biodegradability, rapid metabolism in fish (see IUCLID section 5.3.1) and the estimated BCF/BAF values, this substance is likely to show low bioaccumulation potential. Based on the above information, Fatty acids, C12-16 (even numbered) and C18-unsatd., methyl esters does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.

 

Toxicity (T) Assessment:

The long-term no-observed effect concentrations (NOEC values) reported in the tests conducted with aquatic invertebrates and algae are higher than 0.01 mg/L, and 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,Fatty acids, C12-16 (even numbered) and C18-unsatd., methyl esters does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.

 

In conclusion, Fatty acids, C12-16 (even numbered) and C18-unsatd., methyl esters (CAS No. 1234694-02-0) is considered not to be PBT or vPvB.