Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 ( 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