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Administrative data

Key value for chemical safety assessment

Additional information

Only limited data on mutagenicity are available for EC 270 -128 -1. However, various tests were performed with structure-related substances. These are unbranched mono-or disubstituted diphenylamines. Such substances allow better enzymatic accessibility of the secondary amine group which is the most critical structural feature in regard to genotoxicity. Branched alkyl chains are not a structural alert for genotoxicity. They strongly reduce solubilty in aquous media and reduce cellular availability.

None of the test in-vitro or in vivo revealed a mutagenic potential of either substance. It can therefore be concluded that

EC 270 -128 -1 is non mutagenic in-vitro and in vivo.


Short description of key information:
EC 270-128-1:
in-vitro: negative in SALMONELLA COBAS BACT PILOT TEST with S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 (with and without metabolic activation)

EC 248-295-7:
in-vitro: negative in Ames Test with Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA (with and without metabolic activation)
in-vitro: negative in Chromosome-Aberration in Chinese Hamster Lung (CHL) cell line (CHL/IU)

EC 202-965-5:
in-vitro: in-vitro: negative in Ames Test with S. typhimurium TA 1535, TA 1537, TA 1538 TA 98 and TA 100 and Saccharomyces cerevisiae (with and without metabolic activation)
in-vitro: negative in Mouse Lymphoma Assay
in-vitro: negative in Unscheduled DNA Synthesis Assay in Mammalian Cells
in-vivo: There was no evidence of postimplementation loss in two Dominant Lethal Test in rats and mice.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

There are conclusive but not sufficient data to classify the substance with regard to mutagenicity.

The test substance is not classified for this endpoint in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 1272/2008.