Anthranilic acid

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:

1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only 4 strains tested

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Anthranilic acid

EC Number:

204-287-5

EC Name:

Anthranilic acid

Cas Number:

118-92-3

Molecular formula:

C7H7NO2

IUPAC Name:

2-aminobenzoic acid

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254(R) induced rat liver S9-mix

Test concentrations with justification for top dose:

Dose Range-Finding: 6.7, 10, 33, 67, 100, 333, 667, 1 000, 3 333, 5 000 µg/plate
Experiment: 100, 333, 1 000, 3 333, 5 000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Ethanol, 100 %
- the test substance was dissolved in 50 µL respectively

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 9-aminoacridine, sodium azide, 2-nitrofluorene, 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION:
in agar (plate incorporation)

DURATION
- Exposure duration: incubation for at least 48 to 72 hours

NUMBER OF REPLICATIONS: 3 plates per strain and dose level, including controls, two independent experiments

Evaluation criteria:

negative result: no significant and no dose dependant increase in the number of revertant colonies

Statistics:

Arithmetic means of the counted colonies were calculated.

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

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

The test item did not exert mutagenic activity in the Salmonella typhimurium reverse mutation assay (plate incorporation test) with and without metabolic activation.

Executive summary:

Mutagenic activity of the test item was investigated in Salmonella typhymurium strains 1535, 1537, 98 and 100 with and without metabolic activation (induced rat liver S9-mix) at a maxiumum concentration of 5 000 µg/plate. Under the conditions tested the test compound did not cause a significant increase in the number of revertant colonies and no dose dependent effect was observed.

Therefore the test item is not considered mutagenic under the conditions in this bacterial reverse mutation assay.