Reaction mass of melamine and Nickel, 5,5'-azobis-2,4,6(1H,3H,5H)-pyrimidinetrione complexes

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study - 4 strains tested

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

BAYPLAST Yellow 5GN was investigated using the Salmonella/microsome test (Ames Test) for point mutagenic effects in doses up to 5000 µg per plate on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Bayplast Gelb 5GN

IUPAC Name:

Bayplast Gelb 5GN

Details on test material:

Bayplast Gelb 5GN

Method

Species / strain

Species / strain / cell type:

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

Additional strain / cell type characteristics:

other: all strains are partly deficient in lipopolysaccharide side chains

Metabolic activation:

with and without

Metabolic activation system:

S-9 Mix

Test concentrations with justification for top dose:

first test: 0, 8, 40, 200, 1000, 5000 µg/platerepeat test: 0, 100, 200, 400, 800, 1600, 3200 µg/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2-aminoanthracene

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:

valid

Positive controls validity:

valid

Remarks on result:

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

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Doses up to and including 5000 µg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged

and no inhibition of growth was observed. Substance precipitation occurred at the dose 200 µg per plate and above, such that at 5000 µg per plate, the test was no longer interpretable in Salmonella typhimurium TA 100.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):negative

Executive summary:

BAYPLAST Yellow 5GN was investigated using the Salmonella/microsome test for point mutagenic effects in doses up to 5000 µg per plate on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98.

Doses up to and including 5000 µg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged

and no inhibition of growth was observed. Substance precipitation occurred at the dose 200 µg per plate and above, such that at 5000 µg per plate, the test was no longer interpretable in Salmonella typhimurium TA 100.

Evidence of mutagenic activity of BAYPLAST Yellow 5GN was not seen. No biologically relevant increase in the mutant count,

in comparison with the negative controls, was observed.

Therefore, BAYPLAST Yellow 5GN was considered to be non-mutagenic without and with S9 mix in the Salmonella/microsome

test.

The positive controls sodium azide, nitrofurantoin, 4-nitro-l,2-phenylene diamine and 2-aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.