Pigment Yellow FC 26290

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guiedeline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Pigment Yellow FC 26290 was initially investigated.using the Salmonella/ microsome plate incorporation test for point mutagenic effects in doses of 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. Pigment Yellow FC 26290 was investigated in an independent repeat using the Salmonella/microsome test, modified with S9 mix according to Prival and Mitchell, for point mutagenic effects in doses of up to 4800 µg per tube on the same strains. Without S9 mix preincubation was used.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

content: 83.9% (free acid), 7% H20, 6.3% Ca, 0.2% Na

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:

S9 mix

Test concentrations with justification for top dose:

initial test: 0, 8, 40, 200, 1000, 5000 µg/plate
repeat test: 0, 300, 600, 1200, 2400, 4800 µg/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: positive controls sodium azide, nitrofurantoin and 4-nitro- l,2-phenylene diamine were only used without S9 mix; the positive controls Congo red, benzidine and 2-aminoanthracene were only used with S9 mix

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

In the plate incorporation assay doses of up to and including 200 µg per plate did not cause any bacteriotoxic effects:

Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a weak, strain-specific bacteriotoxic effect, so that this range could nevertheless be used for assessment purposes.

In the plate incorporation assay evidence of mutagenic activity of Pigment Yellow Fe 26290 was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.

Pigment Yellow Fe 26290 was investigated in an independent repeat using the Salmonella/microsome test, modified with S9 mix according to Prival and Mitchell, for point mutagenic effects in doses of up to 4800 µg per tube on the same strains. Without S9 mix preincubation was used.

Doses of up to and including 600 µg per tube did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged

and no inhibition of growth was observed. At higher doses, the substance had a weak, strain-specific bacteriotoxic effect, so that this range could nevertheless be used for assessment purposes.

Evidence of mutagenic activity of Pigment Yellow FC 26290 was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Executive summary:

Pigment Yellow FC 26290 was initially investigated.using the Salmonella/ microsome plate incorporation test for point mutagenic effects in doses of 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. Pigment Yellow FC 26290 was investigated in an independent repeat using the Salmonella/microsome test, modified with S9 mix according to Prival and Mitchell, for point mutagenic effects in doses of up to 4800 µg per tube on the same strains. Without S9 mix preincubation was used.

In the plate incorporation assay doses of up to and including 200 µg per plate did not cause any bacteriotoxic effects:

Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a weak, strain-specific bacteriotoxic effect, so that this range could nevertheless be used for assessment purposes.

In the plate incorporation assay evidence of mutagenic activity of Pigment Yellow Fe 26290 was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.

In the independant repeat doses of up to and including 600 µg per tube did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a weak, strain-specific bacteriotoxic effect, so that this range could nevertheless be used for assessment purposes. Evidence of mutagenic activity of Pigment Yellow FC 26290 was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed.

Pigment Yellow FC 26290 was considered to be nonmutagenic without and with S9 mix in the plate incorporation as well as in the Prival modification of the Salmonella/microsome test.