Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No substance-specific data on the skin sensitizing properties 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.

The sensitising potential of monoethanolamine was studied using the guinea pig maximisation test (Wahlberg and Boman, 1996). Groups of 15 animals were induced intradermally and epicutaneously with 0.6 % (intradermal) and 10.3 % (epicutaneous) solution of monoethanolamine, and then challenged epicutaneously after three weeks with 0.41, 2.05 and 4.1 % test substance at the virgin site. Prior to the topical induction, pretreatment with 10% sodium dodecyl sulphate was carried out. The challenge reactions were read blindly 48 and 72 h after application or the patches. Control groups of twelve animals were given the same treatment except for the inducing amine. After challenge with 4.1 %, 2.05 % and 0.41 % of 2-aminoethanol, 3/15, 2/15 and 3/15 animals reacted positively after 72 hours. Two out of 15 animals showed a reaction to the vehicle. Of the 12 control animals, none reacted to 2-aminoethanol or the vehicle. Based on these results, monoethanolamine is considered to be not sensitizing to skin.

Respectively, monoethanolamine oleate is considered to be not sensitizing.


Migrated from Short description of key information:
Based on the read-across with monoethanolamine, monoethanolamine oleate is considered to be not sensitizing to skin.

Justification for classification or non-classification

Based on the lack of skin sensitizing properties in the parental substance monoethanolamine, classification of monoethanolamine oleate for skin sensitization is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 and EU Directive 67/548/EEC.