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Toxicological information

Genetic toxicity: in vitro

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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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:
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.