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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Genotoxicity of trans-anethole in vitro
Author:
N. J. Gorelick
Year:
1995
Bibliographic source:
Mutation Research 326 (1995) 199-209, Elsevier

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced S9-activation system
Test concentrations with justification for top dose:
S9-activation negative: 0.025, 0.05, 0.1, 0.2
S9-activation positive: 0.013, 0.025, 0.05, 0.1
Vehicle / solvent:
DMSO
Controls
Negative solvent / vehicle controls:
yes
Remarks:
1% (v/v) DMSO
Details on test system and experimental conditions:
cells were exposed to trans-(E)-anethole dissolved in DMSO for 18 h in the absence of S9 and harvested at 20 h from the beginning of treatment. In the presence of S9, cells were exposed to trans-(E)-anethole for 2 h and harvested at 12 h from the beginning of treatment.
100 cells were scored per treatment.

Results and discussion

Test results
Species / strain:
Chinese hamster Ovary (CHO)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

No significant increase in the percentage of cells with chromosome aberrations was detected either in the absence or in the presence of metabolic activation when cells were exposed to trans-(E)-anethole concentrations which drastically reduced the mitotic index.