Reaction product of: 2-[[4-amino-2-ureidophenylazo]-5-[(2-(sulfooxy)ethyl)sulfonyl]]benzenesulfonic acid with 2,4,6-trifluoropyrimidine and partial hydrolysis to the corresponding vinylsulfonyl derivative,mixed potassium/sodium salt

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no E. Coli examined

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

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:

Yellow MGi 1301

IUPAC Name:

Yellow MGi 1301

Test material form:

solid

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:

Rat liver S9 fraction

Test concentrations with justification for top dose:

33, 100, 333, 1000, 2500 and 5000 µg/plate

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

other: 4-nitro-o-phenylene-diamine

Remarks:

without metabolic activation

Controls 2

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

congo red

other: 2-aminoanthracene

Remarks:

with metabolic activation

Results and discussion

Test results

Species / strain:

other: 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

Additional information on results:

A slight toxic effect, evident as a reduction in the number of revertants, was observed in strain TA1537 at 5000 μg/plate in the presence of metabolic activation in experiment II. The plates incubated with the test article showed normal background growth up to 5000 μg/plate with and without S9 mix in all strains used. No substantial increase in revertant colony numbers of any of the four tester strains was observed following treatment with YELLOW MGi 1301 at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.

Applicant's summary and conclusion

Conclusions:

Non mutagenic