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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
Study period:
1982
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Equivalent to accepted guidelines.

Data source

Reference
Reference Type:
publication
Title:
Genotoxicity of Safrole-Related Chemicals in Microbial Test Systems
Author:
Sekizawa J and Shibamoto T
Year:
1982
Bibliographic source:
Mutation Research. 1982; 101: 127-140

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
reliability scoring based on 1997 guideline
Deviations:
no
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Eugenol
EC Number:
202-589-1
EC Name:
Eugenol
Cas Number:
97-53-0
Molecular formula:
C10H12O2
IUPAC Name:
4-allyl-2-methoxyphenol
Details on test material:
- Name of test material (as cited in study report): Eugenol
- Physical state: liquid
- Analytical purity: 98.9%

Method

Target gene:
Histidine or tryptophan
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 and Escherichia coli WP2
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
polychlorinated biphenyl (PCB) induced S9 from male Sprague-Dawley rats
Test concentrations with justification for top dose:
60, 120, 300 and 600 μg/plate
Vehicle / solvent:
Dimethyl sulfoxide (DMSO)
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Dimethyl sulfoxide (DMSO)
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: see Table 1
Details on test system and experimental conditions:
METHOD OF APPLICATION:
Without S9: in agar (plate incorporation)
With S9: preincubation

DURATION
- Preincubation period: 20 minutes at 37°C
- Exposure duration: 48 to 72 hours at 37°C

NUMBER OF REPLICATIONS: 3 to 5 plates per test
Evaluation criteria:
no data
Statistics:
no data

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, TA1538 and Escherichia coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
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 metabolic activation
negative without metabolic activation

Eugenol was not mutagenic under the conditions of the assay.
Executive summary:

The mutagenic potential of eugenol was evaluated in a bacterial reverse mutation assay. Eugenol (60, 120, 300 and 600 μg/plate) did not induce a significant increase in revertant numbers either with Salmonella tester strains (TA98, TA100, TA1535, TA1537, TA1538) or with E. coli WP2uvrA in the absence or presence of S9.