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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:

The PBT Assessment for Fatty acids, C18 unsaturated, trimers, 2-ethylhexyl esters (CAS No. 173832-46-7) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).

 

Persistence

One study according to OECD 301B resulted in 27 – 41% (CO2 evolution) degradation after 28 days. Thus, persistency in the environment (P and vP) cannot be excluded.

Bioaccumulation

An evaluation of the bioaccumulation potential of Fatty acids, C18 unsaturated, trimers, 2-ethylhexyl esters (CAS No. 173832-46-7) is presented in chapter 5.3 indicating that bioaccumulation is expected to be low. Due to its low water solubility, , see IUCLID section 5.3.1) and the estimated BCF/BAF values (BCF: 0.89 L/kg; BAF: 0.89 L/kg), this substance is likely to show low bioaccumulation potential. Based on the above information, the test substance does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.

Toxicity

The L(E)50 values reported in the tests conducted with fish and aquatic invertebrates 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, the test substance does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII. Nevertheless, the toxicity assessment will be re-evaluated when the additional study on aquatic invertebrates (OECD 211) is available.

 

Conclusion

In conclusion, Fatty acids, C18 unsaturated, trimers, 2-ethylhexyl esters is considered not to be PBT or vPvB.