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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian cell study: DNA damage and/or repair
Remarks:
Type of genotoxicity: DNA damage and/or repair
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Peer reviewed data

Data source

Reference
Reference Type:
review article or handbook
Title:
Lack of influence of modulators of epoxide metabolism on the genotoxicity of trans-anethole in freshly isolated rat hepatocytes assessed with the unscheduled DNA synthesis assay
Author:
A.D. Marshall and J. Caldwell
Year:
1996
Bibliographic source:
Food and Chemical Toxicology 34 (1996) 337-345

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)
GLP compliance:
not specified
Type of assay:
unscheduled DNA synthesis

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
trioctanonin (1 mL/kg bw)
Duration of treatment / exposure:
5h
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
1E-6 - 1E-2 M
Basis:
analytical conc.
Remarks:
Doses / Concentrations:
0, 1, 125, 500 mg/kg
Basis:
nominal conc.
Control animals:
yes
Positive control(s):
2-acetylaminofluorene (2-AAF) and methyleugenol

Examinations

Tissues and cell types examined:
hepatocytes

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative