Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
other: assessment report
Title:
Australian Public Assessment Report for Ursodeoxycholic acid
Year:
2010
Bibliographic source:
Australian Government - Department of Health and Ageing Therapeutics Goods Adminsitration. Submission No: PM-2008-03582-3-1. Sponsor: Orphan Australia Pty Ltd

Materials and methods

Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
hamster
Strain:
not specified
Sex:
not specified

Results and discussion

Test results
Sex:
not specified
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
According to results cited by Australian Govermnet in 2010, ursodeoxycholic acid is not genotoxic in the micronucleus test in hamsters.