Oxirane, reaction products with ammonia, distn. residues

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Since Amix TE (CAS 68953-70-8) is composed of at least 75 % of TEA (CAS 102-71-6) and the available data for Amix TE are limited, a read-across to TEA was conducted. In addition to the sensitisation study for TEA mentioned below, the sensitizing potential of Amix TE was investigated in a Guinea Pig Maximization Test according to OECD TG 406 under GLP conditions (

BASF AG 30H0444/952168). Based on the results of a pre-test, animals were dermally injected with 1% of the test substance and well-defined erythema and slight edema were observed. The challenge with a 75% test substance preparation did not cause any skin reaction in the test group (24 and 48 hours after removal of the patch). Since no clinical signs were observed, a second challenge was not performed. One animals in the test group died, after suffering from pneumonia. The cause of death was not related to the test susbtance treatment.

The sensitizing potential of TEA was investigated in a Guinea Pig Maximization 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.

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 sensitization 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, the low frequency of positive reactions to low TEA concentrations in patch-tested patients indicates a very low sensitization potential in humans, and the risk of sensitization to TEA on uncompromised skin seems to be very low (Lessmann, 2009).

Migrated from Short description of key information:
No sensitization potential was reported in guinea pigs upon dermal sensitization and challenge. Although allergic reactions to the test substance have been reported, the substance is jugded to have a very low sensitization potential.

Justification for classification or non-classification

Based on the available data, Amix TE 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.