Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

No substance-specific data on the genotoxicity of monoethanolamine oleate are available. However, according to Article 13 of the REACH legislation, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i. e. applying alternative methods such as in vitro tests, QSARs, grouping and read-across.

Monoethanolamine oleate is a salt of monoethanolamine and oleic acid and is expected to dissociated into the respective monoethanolammonium cation and oleate anion upon uptake by the body. Therefore it is considered to be acceptable to derive lacking information on toxicological properties of monoethanolamine oleate by read-across from its starting materials. Oleic acid is exempted from the registration under REACH according to Annex V of REACH legislation as a non-hazardous substances. Therefore toxicological properties of monoethanolamine oleate are expected to be governed solely by monoethanolamine.

In vitro studies

Gene mutations in bacteria

Monoethanolamine gave negative results in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 strains, and Escherichia coli (WP2 tyr-) strains both in the presence and the absence of metabolic activation at concentration levels up to 2000 µg/plate (Dean et al., 1985a). Concentrations >= 2000 µg/plate of the test substance were cytotoxic.

Chromosome aberrations in mammalian cells The ability of monoethanolamine to induce chromosome aberrations in mammalian cells in vitro was studied in rat hepatocytes, in the absence of metabolic activations, at concentration levels 100 - 400 µg/mL (Dean et al., 1985b). Monoethanolamine gave negative results in the study. No information on cytotoxicity was reported. Gene mutations in mammalian cells

The ability of monoethanolamine to induce gene mutations in mammalian cells was studied in the mouse lymphoma assay, performed according to OECD Guideline 476 and under GLP (Dow, 1999). In this study, the concentrations of 38.1, 76.3, 152.5, 305 and 610 µg/mL were used, both with and without metabolic activation, with the highest concentration representing the limit dose of 10mM. No cytotoxicity was observed. Monoethanolamine did not induce an increase in the mutation frequency both with and without metabolic activation at any concentration level.

In vivo studies

One micronucleus test with mice, performed according to OECD Guideline 474 and under GLP, was available for assessment (BASF AG, 1995). Monoethanolamine was administered orally at a single dose of375, 750 or 1500 mg/kg bw to groups of 5 male and female mice. Animals were sacrificed 24 or 48 h post-dosing and bone marrow slides were prepared.Signs of toxicity were observed in the mid and high dose level groups. There were no biologically relevant, significant differences in the frequency of erythrocytes containing micronuclei either between the solvent control and the 3 dose groups or between the two sacrifice intervals. Based on the results of the study, it was concluded that monoethanolamine gave negative results in the study.

tion, with the highest concentration representing the limit dose of 10mM. No cytotoxicity was observed. Monoethanolamine did not induce an increase in the mutation frequency both with and without metabolic activation at any concentration level.

Short description of key information:
Based on the negative results of in vitro and in vivo studies with the read-across candidate monoethanolamine, monoethanolamine oleate is considered to be not genotoxic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the negative results of in vitro and in vivo studies with a read-across candidate monoethanolamine, classification of monoethanolamine oleate for genotoxicity is not warranted in accordance with EU Directive 67/548 and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.