Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynetrimethanol

Endpoint summary

Additional information

Data on the aquatic toxicity of Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0) are not available.
In accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across to the structurally related substances C18 Fatty acid, dimers, mixed ester with oleic acid and trimethylolpropane (CAS 147256-33-5), Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8) and Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with trimethylolpropane (CAS 85005-23-8) was conducted to fulfil the standard information requirements. 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). According to Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 substances can be considered similar if 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 Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0) mainly consists of mixed esters (mono-, di- or tri-component) of fatty acid dimers of predominantly octadecenoic acid (C18 unsaturated) and octadecenoic acid with propylidynemethanol.Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) is also an ester of the C18-unsatd. dimerised fatty acid and oleic acid with trimethylolpropane. Whereas Fatty acids,C16-18 and C18-unsatd., triesterswith trimethylolpropane (CAS 68002-78-8) is a triester withtrimethylolpropaneesterified with C16-C18 saturated and C18 unsaturated fatty acids. Fatty acids,C14-18 and C18-unsatd., branched and linear, esters with trimethylolpropane (CAS 85005-23-8) contains C14-18 saturated and C18 unsaturated fatty acid chains esterified with trimethylolpropane.

The target and the source substances are characterised by a low water solubility, low vapour pressure and high log Koc values. Thus, the substances are expected to have a similar environmental fate and ecotoxicity profile.
The available short-term and long-term studies indicate that the source substances are not acutely toxic to aquatic organisms up to the limit of water solubility.

In accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5, grouping and read-across the target substance Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol is not considered harmful to aquatic organisms based on the results of the available read across studies conducted with fish, aquatic invertebrates and algae and long-term results on toxicity to aquatic invertebrates.

Experimental data on the acute toxicity of the read-across substance C18 Fatty acid, dimers, mixed ester with oleic acid and trimethylolpropane (CAS 147256-33-5) are available for fish, aquatic invertebrates and algae. No toxicity of the substance was determined up to the limit of water solubility. Comparable results were determined for the second read across substance Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8). The available acute toxicity test on fish, Daphnia and algae determined E(L)C50 values > 100 mg/L.

Data on chronic toxicity are available for Fatty acids, C16-18 and C18-unsatd., triesters with trimethylolpropane (CAS 68002-78-8). The available long-term toxicity test determined no effect on survival and reproduction of the Daphnia magna was not observed up to the limit of water solubility (NOELR ≥ 0.11 g/L).

Data on the toxicity to microorganisms (Pseudomonas putida) are available for Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with trimethylolpropane (CAS 85005-23-8). Adverse effects of the substances to microorganisms were not observed.

The available acute toxicity data for the read-across substances demonstrate that toxic effects of the target substance Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0) up to the limit of water solubility are not likely. Consequently, additional acute and chronic testing is omitted. 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, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0) will not show toxic effects on freshwater organisms up to the limit of the water solubility (WS < 25 µg/L).