Registration Dossier
Registration Dossier
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EC number: 200-186-5 | CAS number: 53-86-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The skin sensitizing effects in the Maurer optimization test were only mild (40% positive only after intradermal provocation).
Cutaneous reactions have been described after therapeutic (partly oral) use as an anti-inflammatory drug.
( e.g.: Duperrat, B et al. (1969): Bulletin de la Societe Francaise de Dermatologie et de Syphiligraphie 76: 26 -27;
Almedya, J et al. (1970): British Journal of Dermatology 83: 707 -711
Beller, U et al. (1987): Contact Dermatitis, 17: 121)
Migrated from Short description of key information:
In the Maurer optimization test 40% of guinea pigs showed a positive response after intradermal challenge on day 35 after induction.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
There is no internal company study investigating the sensitizing properties of indomethacin on the respiratory tract. A literature review in PubMed (www.ncbi.nlm.nih.gov) for adverse effects of Indomethacin resulted in > 440 hits where apparently no report indicated immunological hypersensitivity to Indomethacin. However, Indomethacin was considered to be 100% cross-reactive with Aspirin for the so-called Aspirin intolerance which manifests itself as acute urticaria-angioedema, bronchospasm, severe rhinitis, or shock occuring within few hours after ingestion.
Justification for classification or non-classification
Indomethacin is classified as skin sensitizing (mild) according to 67/548/EEC and Regulation (EC) 1272/2008
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