Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 200-186-5 | CAS number: 53-86-1
Carcinogenicity
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
