Registration Dossier
Registration Dossier
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EC number: 942-072-4 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
There are no data available investigating the aquatic toxicity of Fatty acids, coco, decyl esters (CAS 93455-79-9). In order to fulfil the standard information requirements, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related 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 aquatic 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 and source substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information on the source substances is used to predict the same endpoints for Fatty acids, coco, decyl esters (CAS 93455-79-9).
The target substance is a UVCB substance specified by mainly C12 linear fatty acids esterified with a linear alcohol of a chain length of C10. The first source substanceTetradecanoic acid, tetradecyl ester (CAS 3234-85-3) is a mono-constituent ester of a linear C14 fatty acid and a linear C14 alcohol. The second source substance Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0) is a UVCB substance predominantly consisting of esters with a C8-C10 fatty acid and a C12-C14 alcohol moiety. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
All available experimental data on the source substances performed according to internationally accepted guidelines indicate no evidence of acute and chronic toxicity to aquatic organisms. Data for all three trophic levels are available. No toxicity was observed up to the limit of water solubility in all available experimental studies. The water solubility of the target substance was determined to be < 0.05 mg/L.
The short-term toxicity to fish was determined in a standard OECD guideline study according to OECD 203 (from the source substances CAS 3234-85-3 and CAS 95912-86-0). No mortality was observed after 96 h resulting in a LL(C)50 > 100 mg/L (i.e. above the water solubility limit). The same was recorded for the short-term toxicity to aquatic invertebrates and to aquatic algae. No immobilization of Daphnia magna and no inhibition of growth of aquatic algae were observed in experimental studies according to OECD guidelines up to the limit of water solubility.
Due to the low water solubility, long-term testing on aquatic invertebrates was considered to be necessary to assess the aquatic toxicity. The available study performed with the suitable source substance Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0) resulted in a NOELR (21 d) ≥ 10 mg/L indicating no effects on reproduction up to the limit of water solubility. Long-term toxicity testing to fish was not considered to be necessary since there was no evidence from the available data that fish are more sensitive compared to aquatic invertebrates.
No toxicity to fish was observed in the available acute tests. Thus, in order to avoid unnecessary vertebrate testing, no long-term testing with fish was proposed.
The degradation process in commercial sewage treatment plants is not suspected to be inhibited by the target substance. Available information taken from an OECD 209 study with the source substance Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0)performed with activated sludge from sewage treatment plants did not indicate inhibition of respiration rate of activated sludge microorganisms.
Based on the result from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that Fatty acids, coco, decyl esters (CAS 93455-79-9) exhibits no toxic effects on freshwater organisms up to the limit of the water solubility. 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 substances support the read-across by showing a consistent pattern of results.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.
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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