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:
The sensitising potential of MEA, as well as di- and triethanolamine, was studied using the guinea pig maximisation test (Wahlberg and Boman, 1996). Groups of 15 animals were induced with either MEA, DEA or TEA and then challenged after three weeks with the inducing amine and the two others. 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 (FCA, vehicle, occlusion, etc.) except for the inducing amine. No statistically significant difference between actively induced animals and control animals was observed and there was no indication of cross reactivity.

Migrated from Short description of key information:
Animal data demonstrate that MEA does not have sensitising potential.

Justification for classification or non-classification

Based on the available data, MEA does not have to be classified as sensitising according to Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.