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Key value for chemical safety assessment

Additional information

Dose Range Finding experiment was carried out and 5000 mcg/plate was chosen as the highest dose level for mutation experiment.

Negative (vehicle) and positive control treatments were included for all test strains at each experiment.


Short description of key information:
OECD Guidelines TG 471 (1997) Bacterial Reverse Mutation Test
Strains: Salmonella thyphimurium TA98, TA100, TA1535, TA1537 and one strain of Escherichia coli WP2 uvrA both in absence and presence of metabolic activation system (S9 mix).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

First mutation experiment: pre-incubation method with 5% S9 mix as a metabolic activation system. Employed dose levels were 33.3, 100, 300, 1000, 3000 and 5000 mcg/plate with and without S9 mix. Significant increases of revertant colonies were not observed in any test strains at any dose levels.

Second mutation experiment: pre-incubation method with 10% S9 mix as a metabolic activation system. Employed dose levels were 33.3, 100, 300, 1000, 3000 and 5000 mcg/plate with and without S9 mix. Significant increases of revertant colonies were not observed in any test strains at any dose levels.