Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Remarks:

Screening assay

Adequacy of study:

weight of evidence

Study period:

22. April to 09. May 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

screeing study with summary report only

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

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:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate

EC Number:

274-828-8

EC Name:

Methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate

Cas Number:

70729-65-6

Molecular formula:

C22H24N6O9

IUPAC Name:

methyl N-[3-(acetylamino)-4-[(2,4-dinitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate

Test material form:

solid: particulate/powder

Details on test material:

Disperse Red 311

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 98

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9

Test concentrations with justification for top dose:

phase I 5000, 2500, 1000, 500, 200 and 100 µg/plate
phase II: 500, 200, 100, 50, 20 and 10 µg/plate strain TA98 (±S9) only

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Remarks:

Dimethylsulphoxide (DMSO)

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoacridine, Daunomycin hydrochloride

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

Results and discussion

Test results

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

due to positive results, the assay was repeated ain another late incorporation assay at lower concentration wit TA 98 only

Applicant's summary and conclusion

Conclusions:

Under the conditions of this assay, the test substance gave a positive response with S. typhimurium strain TA98 in the presence and absence of an auxiliary metabolising system (S9).

Executive summary:

The mutagenic activity of Disperse Red 311 (86.7%purity), was investigated in a screening assay in the plate incorporation test using the Salmonella typhimurium strain TA 98. The test substance was dissolved in DMSO, without correction for purity. For screening purposes, the test substance was tested in strain TA98 only (both in the presence and absence of S9), at dose levels of 5000, 2500, 1000, 500, 200 and 100 µg/plate. As the first experiment gave positive results in both the presence and absence of S9, the test compound was be re-tested at dose levels of 500, 200, 100, 50, 20 and 10 µg/plate in strain TA98 (±S9) only, again using a Plate-Incorporation assay.

Reproducible, dose-dependent increases in revertant colony numbers were obtained with and without S9 mix. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test article induced gene mutations by frameshifts in the genome in the tested strain. As the screening test was positive, no further experiment was conducted.