Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment for fatty acids C5-10 esters with dipentaerythritol is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence
One study according to OECD 301B with fatty acids C5-10 esters with dipentaerythritol resulted in 29% (CO2 evolution) degradation after 60 d. Thus, according to the screening criteria the target and the source substances are considered to potentially meet to P/vP criteria.
Bioaccumulation
Fatty acids C5-10 esters with dipentaerythritol is characterized by a low water solubility (< 0.15 mg/L), high log Kow (> 10) and high molecular weights (759 – 1179.77 g/mole). Based on the physico/chemical properties such as low water solubility and high potential for adsorption a reduced availability in water is expected. The high molecular weight of the substance significantly reduces the absorption due to sterical hindrance to cross biological membranes. It can be concluded that the log Kow indicating a potential for bioaccumulation, overestimates the true bioaccumulation potential of the substance. BCF/BAF values estimated by QSAR (BCFBAF v3.01) also indicate that the substance will not be bioaccumulative (all well below 2000 L/kg). Taking all these information into account, it can be concluded that bioaccumulation of fatty acids C5-10 esters with dipentaerythritol is unlikely to occur and the substance is not considered to meet to B/vB criteria.
Toxicity
Neither long-term nor short-term toxicity tests resulted in any toxic effects to aquatic organisms up to the limit of water solubility of Fatty acids C5-10 esters with dipentaerythritol. Furthermore, the substance is not classified according to the consolidated Regulation (EC) No 1272/2008 (dated: 01.01.2017) and further amendments (ATPs). Therefore, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and it is concluded that the substance is not T.
Conclusion
In conclusion the substance is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.
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