Sodium benzoate

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: Limited data available on methods and results, no guidelines and no GLP.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium benzoate

EC Number:

208-534-8

EC Name:

Sodium benzoate

Cas Number:

532-32-1

Molecular formula:

C7H6O2.Na

IUPAC Name:

sodium benzoate

Constituent 2

Reference substance name:

Benzoic acid, sodium salt

IUPAC Name:

Benzoic acid, sodium salt

Details on test material:

No data given.

Method

Target gene:

Histidine gene in S. typhimurium
Tryptophan gene in E. coli

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Species / strain 3

Species / strain / cell type:

E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

0.033, 0.1, 0.33, 1.0, 3.3 and 10 mg/plate.

Vehicle / solvent:

0.067M potassium or sodium phosphate buffer (pH 7.0)

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-anthramine

Remarks:

In the presence of S9 mix for all strains.

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

In the absence of S9 mix for strains TA 98 and TA 1538.

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

In the absence of S9 mix for strains TA100 and TA1535.

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

In the absence of S9 mix for strain TA1537.

Controls 5

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

furylfuramide

Remarks:

In the absence of S9 mix for strain E. coli WP2.

Migrated to IUCLID6: or N-methyl-N'-nitro-N-nitrosoguanidine

Details on test system and experimental conditions:

The standard S. typhimurium plate-incorporation assay was performed in the presence and in the absence of S9 mix, contained 10% Aroclor 1254 induced liver S9 from male Sprague-Dawley rats. The E. coli test was performed by the same procedure as the S. typhimurium assay except that each liter of base agar was supplemented with 10 ml (1% v/v) of Oxoid nutrient broth to provide a trace of tryptophan.

Evaluation criteria:

Test results were considered valid only if the positive control compounds induced increases in mutant counts to at least twice background.

Statistics:

None stated.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without S9

Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Reliability of this study can be demonstrated as 2 (reliable with restrictions) due to limited data available on methods and results, no guidelines and no GLP.

Executive summary:

Reverse mutation assays using S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537, TA 1538 and E. coli WP2 were carried out with and without metabolic activation system of S9 mix. The test was performed using doses of 0.033, 0.1, 0.33, 1.0, 3.3 and 10 mg/plate. All platings were performed in duplicate and concurrent positive controls were run with the test.

The negative result indicated that the test substance was not mutagenic in any tested S. typhimurium and E. coli strains with or without metabolic activation.

Reliability of this study can be demonstrated as 2 (reliable with restrictions) due to limited data available on methods and results, no guidelines and no GLP.