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:
other: The reliability of the study is not assignable because the results are only cited in the Australian Public Assessment Report for Ursodeoxycholic acid (2010) and the complete report of the study is not available.

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 valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Ursodeoxycholic acid is not mutagenic.
Executive summary:

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