2,2'-[[4-[(3,5-dinitro-2-thienyl)azo]phenyl]imino]bisethyl diacetate

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:

1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-[[4-[(3,5-dinitro-2-thienyl)azo]phenyl]imino]bisethyl diacetate

EC Number:

255-940-6

EC Name:

2,2'-[[4-[(3,5-dinitro-2-thienyl)azo]phenyl]imino]bisethyl diacetate

Cas Number:

42783-06-2

Molecular formula:

C18H19N5O8S

IUPAC Name:

2,2'-[[4-[(3,5-dinitro-2-thienyl)azo]phenyl]imino]bisethyl diacetate

Test material form:

solid: particulate/powder

Details on test material:

CI Disperse Blue 284

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S9

Test concentrations with justification for top dose:

up to 1000 µg/plate
the substance is toxic at concentrations of 1000 µg/plate and above

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:

not specified

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

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 Blue 284 (82.4%purity),was investigated in a screening assay in the plate incorporation test using the Salmonella typhimurium strain TA 98. The test article was tested at the concentrations up to 1000 µg/plate up to 1000 µg/plate. The test substance was toxic at concentrations of 1000 µg/plate and above.

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.