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Administrative data

Key value for chemical safety assessment

Additional information

The genotoxic potential of sodium percarbonate has not been tested with in vitro or in vivo methods. In the OECD SIDS dossier for sodium percarbonate (OECD 2006) a read-across approach is chosen to close this data gap. Any genotoxic potential of sodium percarbonate would be attributed to the hydrogen peroxide released during the dissociation of the substance. The in vivo studies on the mutagenicity of hydrogen peroxide are not in support of genotoxicity/mutagenicity (European Commission 2003). No genotoxic potential under in vivo conditions is therefore expected for sodium percarbonate. Sodium carbonate did not cause genotoxicity in vitro in a test on Escherichia coli (OECD 2002).


Short description of key information:
The in vivo studies on the mutagenicity of hydrogen peroxide are not in support of genotoxicity/mutagenicity (European Commission 2003). No genotoxic potential under in vivo conditions is therefore expected for sodium percarbonate. Sodium carbonate did not cause genotoxicity in vitro in a test on Escherichia coli (OECD 2002).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The read-across approach taken in the OECD SIDS dossier for sodium percarbonate is followed to conclude on the genotoxicity of sodium percarbonate. The following text is copied from the OECD SIDS dossier (OECD 2006), section 3.1.6, pages 18-19: "Data on the mutagenicity of sodium percarbonate are not available but it is likely that any test results for sodium percarbonate will be similar to those of hydrogen peroxide due to the release of hydrogen peroxide in aqueous media. The available studies on hydrogen peroxide, most of them, in particular the in vivo studies, were performed according to OECD guidelines and GLP, are not in support of significant genotoxicity/mutagenicity under in vivo conditions. Therefore sodium percarbonate is also unlikely to have any in vivo genotoxic potential. For hydrogen peroxide a wider database in particular with regard to local genotoxicity was however, considered desirable in the EU risk assessment report, once suitable validated methods become available."