Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

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Additional information

No substance-specific data are available for monoethanolamine oleate, however read-across from monoethanolamine is used for the assessment to meet the majority of the standard REACH information requirements. Monoethanolamine oleate is the salt of monoethanolamine and oleic acid. As oleic acid is exempted for registration according to Annex V of REACH Directive 2006/121/EC, the focus is only on the monoethanolammonium cation of monoethanolamine oleate (for more details see reporting format for the analogue approach in Appendix). There is a complete set of data available for monoethanolamine. Besides short-term tests on fish, invertebrates and algae also long-term studies are available.

Guideline studies for short- and long-term toxicity are available for freshwater fish. The critical effect concentrations for monoethanolamine are a 96-h LC50 value of 349 mg/L in carp (Cyprinus carpio) (Huels, 1997a) and a 30-d NOEC of 1.2 mg/L in Japanese killifish (Oryzias latipes) (NITE, 2006). After correction for molecular weight, the effect concentrations for monoethanolamine oleate of 1,963 mg/L for short-term toxicity and 6.75 mg/L for long-term toxicity in fish will be used in the assessment.

For invertebrates short- and long-term toxicity guideline studies are available for Daphnia magna. The critical effect concentrations for monoethanolamine are a 48-h EC50 value of 65 mg/L (Huels, 1997b) and a 21-d NOEC 0.85 mg/L (NITE, 1996a). After correction for molecular weight, the effect concentrations for monoethanolamine oleate of 366 mg/L for short-term toxicity and 4.78 mg/L for long-term toxicity in daphnids will be used in the assessment.

A growth inhibition guideline study is available for freshwater algae. The critical effect concentrations for monoethanolamine are a 72-h EC50 value of 2.5 mg/L and a 72-h NOEC of 1 mg/L in Pseudokirchneriella subcapitata (NITE, 1996b). After correction for molecular weight, the effect concentrations for monoethanolamine oleate of 14.1 mg/L for short-term toxicity and 5.62 mg/L for long-term toxicity in algae will be used in the assessment.

For the toxicity of microorganisms a respiration inhibition guideline study with domestic activated sludge is available (BASF, 1991). The 30-min EC10 for monoethanolamine is >1,000 mg/L. After correction for molecular weight, an effect concentration for monoethanolamine oleate of >5,624 mg/L for STP microorganism toxicity will be used in the assessment.