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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, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS No. 68604-38-6) 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

Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS No. 68604-38-6) is not readily biodegradable. A degradation rate of 7.6% (CO2 evolution) was determined in a study according to OECD 301B. Thus, the substance is considered to be P or vP. 

Bioaccumulation

Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS No. 68604-38-6) has a log Kow of > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. But due to the low water solubility and metabolisation via enzymatic hydrolysis of the substance, a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and the free alcohol (Fukami & Yokoi, 2012).Therefore,a relevant uptake and bioaccumulation in aquatic organisms is not expected forFatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol.This is supported by calculated low BCF/BAF values calculated for the main components of the substance (0.89 L/kg; Arnot-Gobas estimate, upper trophic). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance. Thus the substance is not considered to be B or vB. 

Toxicity

Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS No. 68604-38-6) is considered to be not toxic. The assessment is based on a chronic toxicity study on Daphnia magna according to OECD 211 determining a NOEC (21 d) of ≥ 100 mg/L. Furthermore the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals (See Section 5.9). The criteria for “T” based on mammalian effects are therefore not met.

Conclusion

In conclusion the substance is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.

References

ECHA, 2012. Guidance on information requirements and chemical safety assessment – Chapter R.11: PBT assessment. European Chemicals Agency, Helsinki

Fukami, T. & Yokoi, T. (2012). The Emerging Role of Human Esterases.Drug Metabolism and Pharmacokinetics, Advance publication July 17th, 2012.