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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

There are no data available investigating the aquatic toxicity of Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2). 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, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters.
The target substance Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2) is characterized by two dimerised fatty acid moieties (C18) esterified with the alcohol component 2-ethylhexanol.

The source substance Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4) is characterized as a dimerised ester of two C18:1 fatty acids with 2-ethylhexanol.

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

All experimental studies available for the suitable source substance 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 16 ± 7 µg/L at 20 °C (pH 6.3).

The short-term toxicity to fish was determined in a standard OECD guideline study according to OECD 203 (on the source substance CAS 68334-05-4). No mortality was observed after 96 h resulting in a LL50 > 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.

Since no effects on aquatic organisms from three different trophic levels were observed chronic testing was not considered to be necessary for the assessment of aquatic toxicity. Moreover, 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. The toxicity control from a biodegradation study did not indicate any toxic effects at a limit concentration 12.7 mg/L.

Based on the result from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that the target substance Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters 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 source substances support the read-across by showing a consistent pattern of results.