Registration Dossier
Registration Dossier
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EC number: 204-879-3 | CAS number: 128-13-2
Genetic toxicity: in vitro
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:
- 2 010
- 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 substance name:
- Ursodeoxycholic acid
- EC Number:
- 204-879-3
- EC Name:
- Ursodeoxycholic acid
- Cas Number:
- 128-13-2
- Molecular formula:
- C24H40O4
- IUPAC Name:
- 3,7-dihydroxycholan-24-oic acid
Constituent 1
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.
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