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Baterial Mutation Assay (Ames Test) With Salmonella typhimurium and Escherichia coli (screening study).

The purpose of this study was to assess the potential of the test material to induce gene mutations in vitro in bacterial strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537) and Escherichia coli WP2 uvrA (pKM101).

STUDY DESIGN A single plate incorporation test was conducted for each tester strain both in the presence and absence of rat liver S9-mix, together with appropriate vehicle and positive controls.

RESULTS AND DISCUSSION

The data for the vehicle controls were within or close to the laboratory historical vehicle control ranges. The positive controls induced clear unequivocal increases in numbers of revertant colonies. Therefore the performance of the vehicle and positive controls were consistent with a valid assay. The maximum concentration analysed was limited by precipitation (observed by eye on test plates at the end of incubation) to 500 μg per plate, in the presence and absence of S9-mix. No treatment-related increases in the numbers of revertant colonies were observed at any of the concentrations tested in this study, indicating a negative result.

CONCLUSION

The test material was not mutagenic in the bacterial mutation assay, when tested in either the presence or absence of S9-mix. The maximum concentration analysed was limited by precipitation (observed by eye on the test plates at the end of incubation) to 500 μg per plate, in the presence and absence of S9-mix.


Short description of key information:
The test material was not mutagenic in the bacterial mutation assay, when tested in either the presence or absence of S9-mix.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test material was not mutagenic in the bacterial mutation assay, when tested in either the presence or absence of S9-mix. The maximum concentration analysed was limited by precipitation (observed by eye on the test plates at the end of incubation) to 500 μg per plate, in the presence and absence of S9-mix.