Registration Dossier
Registration Dossier
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EC number: 448-050-6 | CAS number: 444065-11-6
Endpoint summary
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 of 2-(4-tert-butylphenyl)-6-cyano-5-[bis(ethoxycarbonylmethyl)carbamoyloxy]-1 H-pyrrolo[1 ,2-b][1 ,2,4]triazole-7-carboxylic acid-2,6-di-tert-butyl-4-methyl-cyclohexyl ester (UC-141) was evaluated in a Guinea Pig Maximisation Test (GMPT) performed according to OECD 406 (Hooiveld, 2003). The first induction was performed on day 1, when the test animals were treated once with 0.5% UC-141 by intradermal injection. On day 7 all animals were treated with 10% sodium dodecyl sulfate (SDS) to cause skin irritation. On day 8 the topical induction with 50% test substance in corn oil was performed using a semiocclusive dressing for 48 hours. The animals were challenged with 50% UC-141 via topical application for 24 hours on day 22 and rechallenged under the same conditions on day 29.
Slight to moderate erythema was noted at all the injection sites of 10/10 treated and 5/5 control animals, which was a non-specific response to the injections. 48 hours after the first challenge (day 22), no skin effects were observed in the treated animals. At the 72 -hour reading time point, scaling was observed in 4/10 animals exposed to the test substance. None of the treated or control animals showed signs of sensitisation at the 48 - and 72 -hour reading time points. The animals were rechallenged on day 29, due to the scaling observed after the first challenge. No sensitisation reactions were observed in the treated or control animals, 48 and 72 hours after re-challenge. Therefore, the test substance is considered to be not sensitising.
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.
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