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Key value for chemical safety assessment

Additional information

Desoxynojirimycin was shown to be not mutagenic with and without metabolic activation in a bacterial reverse mutation assay with the S. typhimurium strains TA 1535, TA 100, TA 1537 and TA 98.

The study was conducted using concentrations from 20 to 12500 µg per plate. Doses up to and including 100 µg/plate did not cause any bacteriotoxic effects. Higher doses had a weak bacteriotoxic effect, specific to strain, and could therefore nevertheless be used for evaluation up to and including 12500 µg/plate.

Short description of key information:
Gene mutation in vitro (bacterial reverse mutation assay, GLP, Richtlinie 84/449 EWG, B.14): negative in all tested Salmonella typhimurium strains
[Bayer AG, Report No. PH 16914, 1988-07-18]

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.