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Ecotoxicological information

Short-term toxicity to fish

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Description of key information

No toxic effects to fish up to the limit of water solubility (< 0.05 mg/L; OECD 203, EU Method C.1).

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity to fish of fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) (CAS 91031-45-7) are available for this endpoint, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the three structurally related analogue substances ethylene distearate (CAS 627-83-8), 1-methyl-1,2-ethanediyl diisooctadecanoate (CAS 68958-54-3) and butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) was conducted. This read-across is justified in detail in within the analogue justification in IUCLID Section 13 and the overall endpoint summary in IUCLID Section 6.1. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substances were used for the assessment. Both read-across substances represent the upper and the lower limit of fatty acid chain lengths distribution and allow interpolation to the target substance. Nevertheless, as it can be seen in the data matrix of the analogue justification in IUCLID section 13 and the overall summary for aquatic toxicity (IUCLID Section 6.1), all reliable data from the analogue substances support the hazard assessment of each analogue substance by showing a consistent pattern of results.

The first study investigated the short-term toxicity of ethylene distearate (CAS 627-83-8) to freshwater fish (Wetton, 1996). The limit test was performed according to the OECD Guideline 203 under GLP conditions with the rainbow trout (Oncorhynchus mykiss). A semi-static test design was chosen. No effects were observed after 96 h resulting in a LC50 of > 0.3 mg/L (nominal). 0.3 mg/L was the highest concentration which was soluble in the solubiliser tetrahydrofuran without precipitation. No mortality was observed in the control and solvent control.

The second study with the read-across substance 1-methyl-1,2-ethanediyl diisooctadecanoate was performed according to OECD 203 under GLP conditions with the zebrafish Danio rerio (van Egmond, 1997). Five concentrations up to 100 mg/L were tested in a semi-static exposure regime. No effects were observed after an exposure of 96 h resulting in a LC50 > 100 mg/L (nominal).

The third study with butylene glycol dicaprylate / dicaprate was performed according to the EU Method C.1 under GLP conditions (Scholz, 1997). Cyprinus carpio was exposed to a nominal concentration of 1000 mg/L which corresponded to a measured concentration of 14 mg/L for 96 h under semi-static conditions. At the end of the study, no effects were noted resulting in a LC50 of > 14 mg/L, i.e. no effects up to the limit of water solubility of glycol dicaprylate / dicaprate. Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by showing consistent results, it can be concluded that fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) will not exhibit acute effects to fish up to the limit of water solubility.