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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information


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Administrative data

Description of key information

Key value for chemical safety assessment

Justification for classification or non-classification

Classification according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP) is not required.

Additional information

In studies performed for regulatory purposes (i.e. approval of indomethacin as a drug for humans) no tumorigenic effects were evident at doses up to 1.5 mg/kg bw/day (dosing for up to 110 weeks in rats). Indomethacin is not listed in the IARC monographs on the evaluation of carcinogenic risk in humans and neither classified according to German legislation (TRGS-905). Studies where a tumorigenic potential was implied lacked from methodological deficits (Goerttler et al. 1992) or were based on tumors with a high spontaneous incidence rate (Holmäng et al. 1995) and not confirmed by regulatory studies for drug approval.