Barium dibenzoate

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:

comparable to guideline study with acceptable restrictions

Remarks:

Limited reported similar to OECD 471, strain capable of detecting cross-linking agents not included, non GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Initial number of cells was 10E08

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Benzoic acid

EC Number:

200-618-2

EC Name:

Benzoic acid

Cas Number:

65-85-0

Molecular formula:

C7H6O2

IUPAC Name:

Benzoic Acid

Method

Target gene:

Histidine gene

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1538

Species / strain 2

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

0, 20, 100, 500, 1000, 2000 microgram/plate, based on cytotoxicity at 3250 ug/plate

Vehicle / solvent:

DMSO

Controls

Controls 1

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 TA 1537

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Propane sultone

Remarks:

In the absence of S9 mix for strain TA 1535

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene

Remarks:

In the presence of S9 mix for strains TA 98, TA 100 and TA 1538

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: Five days

NUMBER OF REPLICATIONS: 2

No further details provided

Evaluation criteria:

For a compound to be considered positive, it must cause a doubling in the observed reversion index of at least one tester strain. The increase in reversion index must be accompanied by a dose response to increasing concentrations of the test compound.

Statistics:

None stated

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 3250 ug/plate tested separately in TA100

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

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:

cytotoxicity

Remarks:

at 3250 ug/plate tested separately in TA100

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

No information provided

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Positive controls induced mutations within expected ranges.

Applicant's summary and conclusion

Conclusions:

The test substance did not cause a significant increase in the reversion index of any of the tester strains with or without metabolic activation.

Executive summary:

The test was conducted using S. typhimurium strains TA 1538, TA 1535, TA 1537, TA 98 and TA 100 with or without metabolic activation by rat liver microsomes.

Under the conditions of this test, the test substance did not cause a significant increase in the reversion index of any of the tester strains with or without metabolic activation by rat liver microsomes.