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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 skin sensitization potential of TAED was examined in the guinea pig maximization test according to OECD test guideline 406. In the siting test mild to moderate erythema was observed after intradermal injection of 5 % TAED in arachis oil. Topical application of 25 % TAED in petroleum jelly resulted in minimal erythema immediately after patch removal. Based on these results the following concentrations were selected for the main test: 5 % TAED in arachis oil for intradermal induction and 25 % TAED in petrolateum jelly for topical induction and challenge. In the main test 10 guinea pigs were used in the test item and control group. SLS treatment was performed at day 6. One test animal died at day 8. Following challenge treatment there were no skin reactions at the test item or vehicle control sites, at either the 24 or 48 hour reading.

It is concluded that TAED has no skin sensitizing potential in the guinea pig. Furthermore, there is no indication of a skin sensitising effect coming from worker or consumer surveillance data.

Respiratory sensitisation

Based on the data on animal skin sensitisation and repeated dose inhalation studies as well as worker surveillance data it can be assumed that TAED does not have a respiratory sensitisation potential.

Migrated from Short description of key information:
The sensitising potential of TAED was tested in the guinea pig maximization test. There was no positive skin reaction after challenge at both readings (24 and 48 hours after patch removal). It is concluded, that TAED has not skin sensitising potential.

Justification for classification or non-classification

TAED did not cause skin sensitization in the guinea pig maximization test. Thus, TAED is not subject to classification and labelling according to Directive 67/548/EEC and Regulation 1272/2008/EC regarding sensitization.