Eugenol

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

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

Test material information

Constituent 1

Reference substance name:

Eugenol

EC Number:

202-589-1

EC Name:

Eugenol

Cas Number:

97-53-0

Molecular formula:

C10H12O2

IUPAC Name:

2-methoxy-4-(prop-2-en-1-yl)phenol

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.