Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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

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.