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EC number: 947-899-4
CAS number: -
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).
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
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.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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