Registration Dossier
Registration Dossier
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EC number: 306-523-3 | CAS number: 97281-24-8
Endpoint summary
Administrative data
Description of key information
Additional information
The dataset for aquatic toxicity of Fatty acids, C8-10 (even numbered), diesters with neopentyl glycol and di- and triesters with trimethylolpropane (CAS 97281-24-8) is not complete. 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 substance and all 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 comparable results for the target substance Fatty acids, C8-10 (even numbered), diesters with neopentyl glycol and di- and triesters with trimethylolpropane.
The following source substances were used for the read-across approach: Fatty acids, C8-10 (even numbered), di-and triesters with propylidynetrimethanol (CAS 11138-60-6), Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol (CAS 68855-18-5) and Fatty acids, C8-10, triesters with trimethylolpropane (CAS 91050-89-4). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
All experimental studies available for the target substance and suitable source substances were performed according to internationally accepted guidelines. They cover all three trophic levels of an aquatic ecosystem. 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 very low with a concentration of < 0.15 mg/L at 20 °C.
The short-term toxicity to fish did not result in any mortality. Thus, the effect concentrations/loading rates were all greater than the water solubility. 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. These studies are available for the target substance itself.
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.
Due to the low water solubility, long-term testing with aquatic invertebrates was considered to be necessary in order to assess the aquatic toxicity. Both available studies from suitable source substances did not result in inhibition of reproduction up to the limit of water solubility.
The degradation process in commercial sewage treatment plants is not suspected to be inhibited by the target substance. Two studies according to OECD 209 did not indicate any toxic effects on the respiration rate of activated sludge microorganisms.
Based on the results from the target substance and structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that the target substance Fatty acids, C8-10 (even numbered), diesters with neopentyl glycol and di- and triesters with trimethylolpropane (CAS 97281-24-8) exhibits no toxic effects on freshwater organisms up to the limit of the water solubility.
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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