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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key 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
Principles of method if other than guideline:
Not specified.
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:
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 Ames test.