Registration Dossier
Registration Dossier
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EC number: 286-283-3 | CAS number: 85203-92-5
Endpoint summary
Administrative data
Description of key information
Additional information
There are no data available on the biodegradation of Octadecanoic acid, C16-20-branched alkyl esters (CAS 85203-92-5). In order to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related source substances was conducted.
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.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that 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 is characterized as an ester of linear fatty acids and linear alcohols with different compositions of C16-C20 fatty acids and C16-C18 fatty alcohols (C18 fatty acid, C16 alcohol; C16 fatty acid, C18 alcohol; C18 fatty acid, C18 alcohol; C20 fatty acid, C16 alcohol). The source substances are structurally very similar to the target substance. Fatty acids C20-22 (even numbered), C18-22 (even numbered)-alkyl esters (CAS 17671-27-1) is characterized as an ester of C20/C22 fatty acids and C20/C22 alcohols. The second source substance 2-octyldodecyl isooctanoate (CAS 93803-87-3) is and ester of isooctanoate (C18 iso) and 2-octyldodecanol (C20 branched). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
The target substance Octadecanoic acid, C16-20-branched alkyl esters (CAS 85203-92-5) is characterised by a low vapour pressure (VP≤0.0072 Pa at 20 °C, SPARC (v4.6)) and a low water solubility (< 10 µg/L at 20 °C, pH 6.3). Based on the results from the selected source substances, the target substance is readily biodegradable (69.9% after 28 d, OECD 301B; 75.3% after 28 d, OECD 301C). Thus, it is expected that an extensive elimination of the substance in sewage treatment plants will occur. In the case insoluble chemicals enter a standard Sewage Treatment Plant (STP), they 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, 2016). Abiotic degradation via hydrolysis is considered as not relevant for the substance. Moreover, the substance is not volatile (VP≤0.0072 Pa at 20 °C) and thus evaporation to the air and subsequent transport through the atmosphere to other environmental compartments is not likely.
As it can be seen in the data matrix of the analogue justification in IUCLID Section 13, all reliable data from the target and the source substance support the read-across by showing a consistent pattern of results.
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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