Registration Dossier
Registration Dossier
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EC number: 614-590-8 | CAS number: 68552-19-2
Endpoint summary
Administrative data
Description of key information
Additional information
Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2) is characterised by a low vapour pressure (VP<0.0001 Pa at 20 °C, SPARC. version 4.6), a low water solubility (< 5 µg/L at 20 °C, pH = 6.3) and a high log Koc (log Koc > 4, MCI method, KOCWIN v2.00).
Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2) is assessed as readily biodegradable. Studies investigating the biodegradability of the substance are not available. The assessment is therefore based on read across data on the structural analogue substances Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) and Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4). In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” According to Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 substances can be considered similar if their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.The target substance Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2) and the structurally similar source substancesFatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane(CAS 147256-33-5) andFatty acids, C18-unsatd., dimers, 2-ethylhexyl esters(CAS 68334-05-4) result from esterification of 2-ethylhexanol with the respective dimerized or trimerised C18 fatty acid.A detailed justification of the Analogue Approach is attached to IUCLID section 13.
Due to the ready biodegradability persistency of Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol in the environment is not expected. Abiotic degradation by hydrolysis is not relevant for the target substance as indicated by QSAR calculations conducted with the main substance components. The QSAR calculations estimated half-lives in water for the main substance components of >2 years at pH 7 and >95 days at pH 8. The low water solubility of the substance (< 5 µg/L at 20 °C, pH = 6.3) and high log Koc values calculated for the single substance components (log Koc: 4.51 – 23.18) indicate that the substance would mainly distribute to soil and sediment when released to the environment. A distribution to the air is not expected based on the low vapour pressure (VP<0.0001 Pa at 20 °C, SPARC. version 4.6). Thus, an accumulation in air and subsequent transportation and deposition into other environmental compartments is not expected.
However, an exposure of these environmental compartments is unlikely, since the substance is expected to be extensively eliminated in conventional sewage treatment plants. In the case insoluble chemicals enter a standard Sewage Treatment Plant (STP), they will be largely removed in the primary settling tank and fat trap and thus, only limited amounts will get in contact with activated sludge organisms (Guidance on information requirements and chemical safety assessment, Chapter R.7b; ECHA, 2017). The substance is generally not expected to be present in the water column due to the low water solubility. Further, the log Koc values indicate a high potential for adsorption to sewage sludge. Thus, further reduction of the substance concentration in the water column due to adsorption is highly likely (Guidance on information requirements and chemical safety assessment, Chapter R.7b; ECHA, 2017). Thus based on the ready biodegradability and substance characteristics a negligible substance in conventional STP effluents is expected.
Bioaccumulation of Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol is not expected. 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 (MW range of components: 368 – 1368 mg/mol) of the UVCB substance significantly reduces the absorption due to steric hindrance to cross biological membranes. A low bioaccumulation potential is also indicated by the BCF/BAF values estimated for the main substance components (BCF/BAF 0.893 – 17.4/ 0.893 – 160.9 L/kg, Arnot-Gobas estimate, including biotransformation, upper trophic).
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.
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