Registration Dossier
Registration Dossier
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EC number: 947-899-4 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessement of fatty acids C18-C22 (even numbered), tetraesters with pentaerythritol is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistency assessment
Based on the available data, fatty acids C18-C22 (even numbered), tetraesters with pentaerythritol is not readily biodegradable (3% after 28 d, O2 consumption). Thus, the substance may potentially fulfil the P/vP criteria.
Bioaccumulation
Fatty acids C18-C22 (even numbered), tetraesters with pentaerythritol is characterized by a low water solubility (< 0.518 mg/L at 20 °C), high log Kow (> 10) and high molecular weight (1370.31 – 1426.42 g/mol). 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. In addition, no toxicologically relevant effects for mammals were observed in a 90-day oral feeding toxicity study with an analogue substance. It can be concluded that the bioaccumulation potential of fatty acids C18-C22 (even numbered), tetraesters with pentaerythritol is negligible. BCF/BAF values estimated by QSAR (BCFBAF v3.01) also support this assumption (BCF values all well below 2000 L/kg). Please refer to IUCLID section 5.3 for a detailed overview on bioaccumulation of the substance. Thus, taking all information into account, the substance is not considered to be B or vB.
Toxicity
For fatty acids C18-C22 (even numbered), tetraesters with pentaerythritol the available acute effect concentrations are > 0.1 mg/L (fish, aquatic invertebrates, algae) and the chronic effect concentration (daphnia, algae) is > 0.01 mg/L. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B) or toxic for reproduction (category 1A, 1B or 2) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. In conclusion, the criteria set out in Annex XIII of Regulation (EC) No 1907/2006 are not met and the test substance is not considered to meet the T criterion.
In conclusion, the substance is not PBT/vPvB.
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