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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

A valid screening criterion to evaluate persistence (P) is the potential of a substance for ready biodegradability. Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS-No 95912-89-3) is readily biodegradable (78.1-84.7% 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

An evaluation of the bioaccumulation potential of Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS-No 95912-89-3) is presented in Section 5.3 of the technical dossier indicating that bioaccumulation is expected to be low. Due to its low water solubility, ready biodegradability, high molecular weight which significantly reduces the absorption due to steric hindrance to cross biological membranes (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, the test substance does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.

Toxicity

Long-term toxicity testing with Desmodesmus subspicatus resulted in a NOELR of ≥ 100 mg/L (OECD 201; nominal). The L(E)50 values reported in the tests conducted with fish, aquatic invertebrates and algae show no toxic effects in the range of water solubility 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.

 

Conclusion

In conclusion, Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane is considered not to be PBT or vPvB.