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EC number: 306-522-8 | CAS number: 97281-23-7
Endpoint summary
Administrative data
Description of key information
Additional information
The substance fatty acids, C16-18, 2-hydroxyethyl ester, (CAS 97281-23-7) is characterised by a low vapour pressure (<0.0001 Pa at 20 °C, SPARC (v4.6)), a low water solubility (≤ 5 µg/L at 20 °C, pH=6.3) and a log Koc indicating a potential for adsorption to soil and sediment particles (log Koc ≥ 3.35, MCI method, KOCWIN v2.00). Based on the result from a biodegradation study according to OECD 301B the substance is readily biodegradable (95% after 28 d, read across).
Based on this result, fatty acids, C16-18, 2-hydroxyethyl ester, (CAS 97281-23-7) will be significantly degraded in sewage treatment plants. In the case insoluble chemicals enter a standard Sewage Treatment Plant (STP), it will be extensively removed in the primary settling tank and fat trap and thus, only limited amounts will get in contact with activated sludge organisms, according to the Guidance on information requirements and chemical safety assessment, Chapter R.7b (ECHA, 2014). As a result of the potential for adsorption of the substance (log Koc ≥ 3.35, MCI method, KOCWIN v2.00) a removal from the water column to a significant degree by adsorption to sewage sludge can be expected (Guidance on information requirements and chemical safety assessment, Chapter R.7b, ECHA, 2014). In conclusion, the concentration of the substance in conventional STP effluents is presumably marginal. Due to ready biodegradability and based on the chemical structure, abiotic degradation via hydrolysis is considered as not relevant for the substance. Moreover, the substance is not volatile (VP < 0.0001 Pa at 20 °C) and thus evaporation to the air and subsequent transport through the atmosphere to other environmental compartments is not likely.
Based on the physico/chemical properties such as low water solubility and potential for adsorption a reduced availability in water is expected. Moreover, the substance is expected to be metabolised in aquatic organisms by breaking the ester bond and metabolisation of the enzymatic hydrolysis products (fatty acid and fatty alcohol).
For the assessment of fatty acids, C16-18, 2-hydroxyethyl ester, (CAS 97281-23-7) a read-across approach was chosen, based on data from similar fatty acid esters.
Justification for the analogue approach (read-across)
Fatty acid esters are generally produced by chemical reaction of an alcohol with an organic acid in the presence of an acid catalyst (Radzi et al., 2005). The esterification reaction is started by a transfer of a proton from the acid catalyst to the acid to form an alkyloxonium ion. The acid is protonated on its carbonyl oxygen followed by a nucleophilic addition of a molecule of the alcohol to a carbonyl carbon of acid. An intermediate product is formed. This intermediate product loses a water molecule and a proton to give an ester (Liu et al, 2006; Lilja et al., 2005; Gubicza et al., 2000; Zhao, 2000).
The available information on ecotoxicological properties of the glycol esters source and target substances show that no effects up to the limit of water solubility occurred in either acute and chronic study(ies) representing the source and target substances. Moreover, all source and target substances are readily biodegradable and show a similar pattern in environmental distribution and behaviour characterised by low water solubility, high log Kow and log Koc.
Glycol esters have a common metabolic fate that involves a stepwise hydrolysis of the esterbonds by gastrointestinal enzymes by which the breakdown of glycol esters results in structurally similar chemicals, the fatty acid component and the respective alcohol (Long, 1958; Lehninger, 1970; Mattson and Volpenhein, 1972). Following hydrolysis of the ester bond, the breakdown product will be absorbed and metabolised. The toxicological properties show that all source and target substances have similar toxicokinetic behaviour and that the constant pattern consists in a lack of potency change of properties across the category, explained by the common metabolic fate of glycol esters independently of the fatty acid chain length and degree of glycol substitution.
A detailed justification for the analogue approach and read-across is provided in the technical dossier (see IUCLID Section 13).
References:
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within the CSR.
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