Registration Dossier
Registration Dossier
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EC number: 943-730-3 | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment for Monopentaerythritol tetraesters and dipentaerythritol hexaesters of 2-ethylhexanoic and n-valeric acids 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
Monopentaerythritol tetraesters and dipentaerythritol hexaesters of 2-ethylhexanoic and n-valeric acids is not readily biodegradable. A degradation rate of 4.6 – 28 % (CO2 evolution) was determined in a study according to OECD 301B. Thus, the substance is considered to bepotentially P and vP. [Mue1]
Bioaccumulation
Monopentaerythritol tetraesters and dipentaerythritol hexaesters of 2-ethylhexanoic and n-valeric acids is characterized by a low water solubility (1.5 - 5.1 mg/L) and a high log Kow (> 10) for most of its components. Based on the physico/chemical properties such as low water solubility and high potential for adsorption a reduced availability in water is expected. It can be concluded that the bioaccumulation potential of Monopentaerythritol tetraesters and dipentaerythritol hexaesters of 2-ethylhexanoic and n-valeric acids is negligible (BCF/BAF values experimentally determined and estimated by QSAR (BCFBAF v3.01) also support this assumption (BCF values all well below 2000 L/kg). Also the high log Kow (>10) supports the assumption that bioaccumulation is unlikely (Guidance on information requirements and chemical safety assessment, Chapter R.11, (ECHA, 2017)). 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
Monopentaerythritol tetraesters and dipentaerythritol hexaesters of 2-ethylhexanoic and n-valeric acids is considered to be not toxic. The assessment is based on a chronic toxicity study on Daphnia magna according to OECD 211 determining no effects within the limit of water solubility. Furthermore the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals. The criteria for “T” based on mammalian effects are therefore not met.
In conclusion, the substance is not PBT/vPvB.
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