[No public or meaningful name is available]

Endpoint summary

Additional information

Four studies are available investigating the aquatic toxicity of Glycerides, C16-18 (even numbered) mono- and di- and their citrates (EC 701-358-7) to freshwater fish, aquatic invertebrates, algae and aquatic plants. In order to fulfil the standard information requirements and to strengthen the overall dataset, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance, Glycerides, C16 - 18 (even numbered) mono-, di-, and tri-, hydrogenated, citrates, potassium salt (CAS 917440-38-6), was conducted.

All experimental studies available for the target substance and the suitable source substance were performed according to internationally accepted guidelines and GLP. They cover four trophic levels of an aquatic ecosystem. No toxicity was observed up to the limit of water solubility (129 µg/L) in all available experimental studies.

The short-term toxicity to fish was determined in a limit test according to OECD 203 for the target substance. The test item concentrations 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 exposure with 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 OECD 203 for the source substance Glycerides, C16 - 18 (even numbered) mono-, di-, and tri-, hydrogenated, citrates, potassium salt (CAS 917440-38-6). No mortality was observed after 96 h for the tested concentration. Therefore, a LL50 (96 h) of > 100 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 or algae. Thus, in order to avoid unnecessary vertebrate testing, no additional long-term test 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 > 0.214 mg/L (measured geom. mean) was derived. Since the target substance is poorly soluble in water a testing proposal is submitted in order to investigate chronic effects to aquatic invertebrates. This approach is in line with Annex VII of Regulation (EC) No 1907/2006.

The toxicity to algae was conducted for the source substance Glycerides, C16 - 18 (even numbered) mono-, di-, and tri-, hydrogenated, citrates, potassium salt (CAS 917440-38-6). No effects on algae are expected up to the limit of its water solubility (ErL50 (72 h) > 100 mg/L (nominal), and NOELR (72 h) ≥ 100 mg/L (nominal) (Pseudokirchneriella subcapitata).

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 (7 d) 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 performed according to OECD 301 F for the source substance Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates did not indicate any inhibition of biodegradation up to a concentration of 22 mg/L (NOEC (14 d) of ≥ 22 mg/L BOD).

Based on the results from the target substance and from a structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be concluded that the target substance Glycerides, C16-18 (even numbered) mono- and di- and their citrates exhibits no toxic effects on freshwater organisms up to the limit of the water solubility (129 µg/L).