2-({1-[(2-methoxyphenyl)amino]-1,3-dioxobutan-2-yl}diazenyl)benzoic acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: DNA damage and/or repair

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

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

Test material information

Constituent 1

Reference substance name:

2-(2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl)benzoic acid

EC Number:

683-287-0

Cas Number:

877670-90-1

Molecular formula:

C18H17N3O5

IUPAC Name:

2-(2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl)benzoic acid

Details on test material:

Batch 939-76

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

mitochondrial supernatant (S9)

Test concentrations with justification for top dose:

5000; 1581.1; 500; 158.1; 50; 15.81 and 5 g/plate

Vehicle / solvent:

Dimethyl sulfoxide (DMSO)

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

yes

Remarks:

Distilled Water

Positive controls:

yes

Positive control substance:

other: Depends on strain and metabolic activation

Results and discussion

Test results

Test results 1

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:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

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

In conclusion, the test item AA-AAOA (Anthranilic Acid-AAOA Coupling) has no mutagenic activity on the applied bacterial tester strains under the test conditions used in this study.

Executive summary:

The test item AA-AAOA (Anthranilic Acid-AAOA Coupling) was tested with regard to a potential mutagenic activity using the Bacterial Reverse Mutation Assay. The experiments were carried out using histidine-requiring auxotroph strains of Salmonella typhimurium (Salmonella typhimurium TA98, TA100, TA1535 and TA1537), and the tryptophan-requiring auxotroph strain of Escherichia coli (Escherichia coli WP2 uvrA) in the presence and absence of a post mitochondrial supernatant (S9) prepared from rat livers of phenobarbital/-naphthoflavone-induced rats (used in the plate incorporation method) and from hamster livers of uninduced hamsters (used in the pre-incubation method). The study included a Preliminary Solubility Test, a Preliminary Range Finding Test (Informatory Toxicity Test), an Initial Mutation Test (Plate Incorporation Test using Rat Liver S9), and a Confirmatory Mutation Test (Pre-Incubation Test using Hamster Liver S9). The test item concentrations in the Initial and Confirmatory Mutation Tests were: 5000; 1581.1; 500; 158.1; 50; 15.81 and 5 g/plate

The revertant colony numbers of solvent control plates without S9 mix were within the historical control data range. The reference mutagens showed the expected increase in induced revertant colonies. The reported data of this mutagenicity assay show (see Appendix 1 to 4) that under the experimental conditions applied the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.