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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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 / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1538
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
Controlsopen allclose all
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
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
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 resultsopen allclose all
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
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.