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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
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.