Fatty acids, C16-18 and C18-unsatd., Et esters

Endpoint summary

Additional information

Data investigating the aquatic toxicity of Fatty acids, C16-18 and C18-unsatd., ethyl esters (CAS 85049-36-1) are not available.
In accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances 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 to be similar if their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.

Fatty acids, C16-18 and C18-unsatd., ethyl esters (CAS 85049-36-1) and the read across substances Isopropyl oleate (CAS 112-11-8) and Fatty acids, C16-18 and C18-unsaturated isobutyl esters (CAS 84988-79-4) are monoesters of primary and secondary (isopropanol) alcohols C2-C4 and fatty acids. The fatty acid moiety comprises carbon chain lengths from C16-C18 and includes linear saturated and unsaturated fatty acid chains. The target substance and the source substances are characterised by a low water solubility, low vapour pressure and high log Koc. 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 or chronically toxic to aquatic organisms up to the limit of water solubility of the source substances.

Data on the short-term toxicity to fish are covered by a read across to Isopropyl oleate (CAS 112-11-8). The acute toxicity of the substance to Cyprinus carpio was investigated in a standard OECD guideline study according to OECD 203. No mortality was observed after 96 h resulting in a LC50 > 100 mg/L (i.e. above the water solubility limit). The result is supported by a test performed by Loeb and Kelly (1963). In the static test Cyprinus carpio were exposed to the substance for 70 hours. A LC0 >= 118 mg/kg bdwt. based on mortality was observed.

The available short-term toxicity tests on aquatic invertebrates conducted with Fatty acids, C16-18 and C18-unsaturated isobutyl esters (CAS 84988-79-4) and Isopropyl oleate (CAS 112-11-8) reported no immobilization up to the limit of water solubility or the highest attainable concentration in test solution (EL(LC)50 > 100 mg/L). The assessment of the algal toxicity was based on a study available for Fatty acids, C16-18 and C18-unsaturated isobutyl esters (CAS 84988-79-4). The algae were exposed to filtered and unfiltered test solution respectively. An EC50 <100 mg/L was determined in the unfiltered test solution. Whereas an EL50>100 mg/L was reported for the filtered test solution. The observed effects in the unfiltered test solution were related to physical effects of the test substance.

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 Fatty acids, C16-18 and C18-unsaturated isobutyl esters (CAS 84988-79-4) resulted in a NOELR (21 d) ≥ 100 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 available study on toxicity to aquatic microorganisms conducted with the source substance Isopropyl oleate (CAS 112-11-8) determined no detrimental effects.

Based on the result from a structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that Fatty acids, C16-18 and C18-unsatd., ethyl esters (CAS 85049-36-1) is not acutely or chronically toxic to freshwater organisms up to the limit of the water solubility (WS < 0.05 mg/L).