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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Additional information

Ambiguous results for genotoxicity testing were restricted to one publication (Kuboyama 1992) on an Ames test with positive findings for only the TA100 strain after metabolic activation with S9-rat liver mix (negative with S9-mix of other species) and two publications (Kuboyama 1992, Kadatoni 1984) on DNA-repair tests in B. subtilis (M45/H17 strain) as findings were borderline and/or occurred together with cytotoxicity. These results were not confirmed in other studies. The main number of genotoxicity studies in bacteria and mammalian cells revealed no mutagenic effects.

The positive genotoxicity in vivo test by Shobda Devi (1987) has some relevant methodological deficiencies so that the study can not be used for hazard and risk assessment.

Short description of key information:
Indomethacin was tested for genotoxicity in number of in-vitro (Ames mutation test and DNA-repair tests) and in in-vivo genotoxicity tests.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

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