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Endpoint summary

Additional information

Three studies are available investigating the aquatic toxicity of for Fatty acids, C16-18 (even numbered), esters with glycerol oligomers to freshwater fish, aquatic invertebrates and Lemna gibba. In order to fulfill the standard information requirements, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5) and Glycerides,C14-18 and C16-18 unsaturated, mono-, di- and tri- (CAS No. 91052-28-7) was conducted.

All experimental studies available for the target substance and the suitable source substances were performed according or similar 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 (91.9 µg/L) in all available experimental studies.

The short-term toxicity to fish was determined in a limit test according to OECD 203 for target substance. The test item concentration could not be analytically quantified during the whole experiment as all measured concentrations were below the Limit of Quantification (LOQ = 0.038 mg/L). Therefore, all results are expressed as the nominal loading rate WAF. No effects were observed after 96 h for the tested concentration. Therefore, a LL50 (96 h) of > 100 mg/L (nominal) was derived. This result is supported with a study for a structurally and chemically related source substance. The short-term toxicity to fish was determined in a limit test according to OSPARCOM (2005-11), equivalent to OECD 203, for the source substance Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5). No mortality was observed after 96 h for the tested concentration.Therefore, a LL50 (96 h) of > 2300 mg/L (nominal) was derived.

Long-term toxicity testing to fish was not considered to be necessary since there was no toxicity to fish observed in the available acute tests and there was no evidence from the available data that fish are more sensitive compared to aquatic invertebrates. Long-term testing to daphnia shows no effects on survival, reproduction or any other adverse effects at the end of the exposure period (NOELR ≥ 10 mg/L, nominal).Thus, in order to avoid unnecessary vertebrate testing, no long-term testing with fish was proposed.

One short-term toxicity test on aquatic invertebrates is available for the target substance. No effects were observed after 48 h at the tested concentration. Therefore, an EC50 (48 h) of > 0.08 mg/L (measured geom. mean) was derived.No effects on Daphnia magna are expected up to the limit of its water solubility (91.9 µg/L).

Long-term testing with aquatic invertebrates was conducted according to OECD 211 with the source substance Glycerides,C14-18 and C16-18 unsaturated, mono-, di- and tri- (CAS No. 91052-28-7).At the end of the exposure period (21d), no effects on survival, reproduction or any other adverse effects were reported (NOELR ≥ 10 mg/L, nominal).

The toxicity to algae was conducted for the source substances Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5) and Glycerides,C14-18 and C16-18 unsaturated, mono-, di- and tri- (CAS No. 91052-28-7). No effects on algae are expected up to the limit of its water solubility of 91.9 µg/L (EL50 (72 h) = 2286.77 mg/L (nominal, Skeletonema costatum); NOELR (72 h) = 1000 mg/L (nominal, Skeletonema costatum); ErL50 (72h) > 320 mg/L (nominal, Desmodesmus subspicatus); NOELR = 32 mg/L (nominal, Desmodesmus subspicatus)).

In addition, the toxicity of the target substance to Lemna gibba was assessed. The test item concentration could not be analytically quantified during the whole experiment as all measured concentrations were below the Limit of Quantification (LOQ = 0.038 mg/L). Therefore, all results are expressed as the nominal loading rate WAF. No inhibition was observed after 7 d for the tested concentration.Therefore, an EL50 (7d) of > 100 mg/L (nominal) and a NOEC (7 d) of ≥ 100 mg/L (nominal) was derived.

The degradation process in commercial sewage treatment plants is not expected to be inhibited by the target substance.A toxicity control from a biodegradation study similar to ISO 10708 for the source substance Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol] (CAS 91050-80-5)did not indicate any inhibition of biodegradation up to a concentration of 20 mg/L (NOEC (14 d) of ≥ 20 mg/L BOD) and show readily biodegradability.

Based on the results from the target substance and from 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, C16-18 (even numbered), esters with glycerol oligomers exhibits no toxic effects on freshwater organisms up to the limit of the water solubility (91.9 µg/L).