Benzoic acid, 5-fluoro-2-nitro-, methyl ester

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Directive 92/69, L383 A, Annex B14

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

5-Fluoro-2-nitrobenzoic acid methyl ester

EC Number:

609-664-1

Cas Number:

393-85-1

Molecular formula:

C8H6FNO4

IUPAC Name:

5-Fluoro-2-nitrobenzoic acid methyl ester

Constituent 2

Reference substance name:

2-Nitro-5-fluorobenzoic Acid Methyl Ester

IUPAC Name:

2-Nitro-5-fluorobenzoic Acid Methyl Ester

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Test concentrations with justification for top dose:

The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from a rat liver homogenate. A dose range of 8 different doses from 0.8 µg/plate to 2500 µg/plate was used

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 2-Aminoanthracence

Evaluation criteria:

Criteria for positive response: A test article is classified mutagenic if either of the following conditions under a) and b) is achieved:
a) a test article produces at least a 2-fold increase in the mean number of revertants per plate at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn.
b) A test article induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of appropriate vehicle control in at least two to three concentrations of the test article at complete bacterial background lawn.

Applicant's summary and conclusion

Conclusions:

Based to this study it can be stated that the testing substance 5-Fluoro-2-nitrobenzoic acid methyl ester is mutagenic in these bacterial test systems in the presence and in the absence of a metabolic activation.