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EC number: 905-898-6
CAS number: -
The sensitising potential of TEA was investigated in a Guinea Pig
Maximisation Test according to OECD TG 406 under GLP conditions. Based
on the results of a pre-test, animals were dermally injected 1% TEA on
day 1, followed day 7 by an epicutaneous induction (occlusive) with 0.3
- 0.5 mL undiluted TEA for 48 hours, and a dermal challenge (occlusive)
with 75 and 50% TEA for 24 hours on day 21. Dermal reactions were
evaluated according to Draize 24 and 48 hours after the start of the
dermal challenge. No clinical signs were noticed. One animal out of 10
showed a skin reaction. Triethanolamine was concluded to be a weak
Regarding the available human data, the positive reactions interpreted
as allergic seem to be caused by exposure to TEA in cosmetics and/or
topical therapeutic preparations possibly on damaged skin. The diagnosis
of TEA contact sensitisation should therefore not be based on a positive
patch test reaction alone but on a combination of history and –
preferably – validation tests.
The negative experimental findings in animals and the level of exposure
to TEA in the population, together with the low frequency of positive
reactions to low TEA concentrations in patch-tested patients indicate a
very low sensitisation potential in humans, and the risk of
sensitisation to TEA on uncompromised skin seems to be very low
Migrated from Short description of key information:
For the major constituent, triethanolamine, no sensitisation potential was reported in guinea pigs upon dermal sensitisation and challenge. Although allergic reactions to TEA have been reported, the substance is judged to have a very low sensitisation potential.
Based on the available data, the substance does not need to be
classified according to Directive 67/548/EEC and according to the EU
Classification, Labelling and Packaging of Substances and Mixtures (CLP)
Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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