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 skin sensitising potential of TS-2863 (2-(2-hexyl-decyloxy)-benzamide) was evaluated in a Guinea Pig Maximisation Test (GMPT) performed according to OECD 406 (Pels Rijcken, 1998). However, the test substance was applied with a semi-occlusive dressing. On day 1, ten animals were intradermally injected with a 5% concentration of the test substance. On day 8, 50% test substance was applied topically with a semi-occlusive dressing for 48 hours. On day 22, all the animals were challenged with 20% TS-2863 via topical application for 24 hours.

Slight to moderate erythema or necrosis was noted at most of the injection sites of 10/10 treated and 5/5 control animals 24 hours after intradermal induction, due to the injection and not to exposure to the test substance. No skin effects were observed in the treated or control group after the challenge. Under the conditions of this study, the test substance is not considered to be a skin sensitiser.


Migrated from Short description of key information:
Skin (OECD 406): not sensitising (Guinea pig maximisation test)

Justification for classification or non-classification

The available data on the skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.