methyl 5-(bis(methoxycarbonylmethylamino))-4-cyano-3-methoxycarbonylmethylthiophen-2-carboxylate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2003

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Metabolic activation system:

The S9 mix prepared from a liver microsomal fraction (S9 fractions) of rats induced with Aroclor 1254

Test concentrations with justification for top dose:

312.5 microg / plate to 5000 microg / plate

Vehicle / solvent:

DMSO

Details on test system and experimental conditions:

- vehicle as negative controls
- adequate positive controls for each strain

Evaluation criteria:

number of revertant vs. negative controls; dose-relationship; historical data

Statistics:

yes (vs. negative controls)

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 1535, TA 1537, TA 98 , TA 100 and TA102

Metabolic activation:

with and without

Genotoxicity:

other: minimal increase in revertant on strain TA102 only, with metabolic activation only, at high concentrations (> 3600 µg/plate)

Cytotoxicity / choice of top concentrations:

other: thinning of bacterial lawn from 1250 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

Metabolic activation: with and without (arochlor induced rat S9).

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
other: positive with metabolic activation, in only one strain and at very high concentrations (from 3600 µg/plate)
negative without metabolic activation