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 TEA was investigated in a Guinea Pig Maximisation Test according to OECD TG 406 under GLP conditions (Hoechst, 1988). Based on the results of a pre-test, animals were dermally injected twice with 0.1 mL 2% TEA on day 1, followed by an epicutaneous induction (occlusive) with 0.5 mL undiluted TEA for 48 hours starting on day 9, and a dermal challenge (occlusive) with 0.5 mL 10% TEA for 24 hours on day 22. Dermal reactions were evaluated according to Draize 48 and 72 hours after the start of the dermal challenge. No clinical signs were noticed and all readings were negative.

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 (Lessmann, 2009).

Migrated from Short description of key information:
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.

Justification for classification or non-classification

Based on the available data, TEA 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.