2-Thiophenecarboxylic acid, 5-amino-4-cyano-3-methyl-, methyl ester

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial forward mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

methyl 5-amino-4-cyano-3-methylthiophene-2-carboxylate

EC Number:

700-422-1

Cas Number:

61320-65-8

Molecular formula:

C8 H8 N2 O2 S

IUPAC Name:

methyl 5-amino-4-cyano-3-methylthiophene-2-carboxylate

Details on test material:

content: 99.1 %
batch no. BOS 2589

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9-mix of livers from adult male Sprague-Dawley rats induced with Aroclor 1254a

Test concentrations with justification for top dose:

plate incorporation methodology: 0 (solvent control), 5000, 1600, 500, 160 or 50 µg/plate
due to precipitation at 5000 µg/plate:
preincubation methodology: 0 (solvent control), 2000, 1000, 500, 250. 125 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: Sodium azide, Nitrofurantoin, 4-Nitro-1,2-phenylene diamine, Mitomycin C, Cumene hydroperoxid, 2-Aminoanthracene

Details on test system and experimental conditions:

as described in the respective OECD Guideline:
plate incorporation methodology
preincubation methodology

Evaluation criteria:

A reproducibel and dose related increase in mutant counts of at least one strain is considered to be positive result. For TA1535, TA100, TA1537 and TA98 thid indrease should be about twice tht of the negative controlls. For TA102 an increase of about 100 mutants should be reached. Otherwise, the result is evaluated as negative.
However, these criteria may be overruled by good scientific judgement.
In case of questionable results, investigations should should continue, possibly with modifications until a final evaluation is possible.

Statistics:

no

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity, but tested up to precipitating concentrations

Remarks:

5000 µg/plate (plate incorporation assay), 2000 µg/plate (preincubation assay)

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

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):
negative

Executive summary:

Diazokomponente Rot B was investigated using the Salmonella/microsome test according to OECD TG 471 using TA1535, TA100, TA1537, TA98 and TA 102 in the presence and in the absence of a metabolic activation system. Initially the plate incorporation methodology was used and concentrations up to and including 5000 µg/plate. Due to precipitation at 5000 µg/plate the following preincubation methodoloy was done with concentrations up to and including 2000 µg/tube showing predipitation from 1000 µg/tube onwareds. Evidence of mutagenic activity of Diazokomponente Rot B was not seen. No biologically relevant increase in the mutant count in comparison th the negative controls was observed in any of the strains tested with and without S9 -mix in the plate incorporation as well as in the preincubation modification under the experimental conditions applied. The positive controls were functional.

Therefore, Diazokomponente Rot B was considered to be non-mutagenic without and with S9-mix in the plate incorporation as well as in the preincubation modification of the Salmonella / microsme test (Bayer 2011).