Registration Dossier

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key 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
Principles of method if other than guideline:
Amest test
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Test results
Species / strain:
not specified
Metabolic activation:
not specified
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
According to results cited by Australian Government in 2010, ursodeoxycholic acid is not genotoxic in the Ames test.