tert-butyl(6-{2-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]vinyl}(4S,6S)-2,2-dimethyl[1,3]dioxan-4-yl)acetate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Adequacy of study:

other information

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Annex V B13/B14

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Method

Species / strain

Species / strain / cell type:

bacteria, other: Salmonella typhimurium TA1535, TA1537, TA98, TA100 Escherichia coli WP2 (pKM101), WP2 uvrA (pKM101)

Metabolic activation system:

Liver S9 derived from phenobarbital/Beta-naphthoflavone-induced Sprague Dawley rats

Test concentrations with justification for top dose:

Concentration range in the main test (with metabolic activation): 100 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 100 ... 5000 µg/plate

Vehicle / solvent:

Solvent: Dried dimethylsulphoxide

Details on test system and experimental conditions:

Concentration of the test substance resulting in precipitation: 1000 µg/plate

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation