Registration Dossier

Administrative data

sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Although the study is cited by a well recognized database (RTECS), only results of the study are available, and no other information is reported.

Data source

Reference Type:
secondary source
No information
Bibliographic source:
Yakuri to Chiryo. Pharmacology and Therapeutics. (Raifu Saiensu Shuppan K.K., 2-5-13, Yaesu, Chuo-ku, Tokyo 104, Japan), 10,4529

Materials and methods

Test guideline
no guideline available
Principles of method if other than guideline:
Rats were orally administered with ursodeoxycholic acid for a period of 26 weeks.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ursodeoxycholic acid
EC Number:
EC Name:
Ursodeoxycholic acid
Cas Number:
Molecular formula:
3,7-dihydroxycholan-24-oic acid

Test animals


Administration / exposure

Route of administration:
oral: unspecified
not specified
Analytical verification of doses or concentrations:
not specified

Results and discussion

Results of examinations

Clinical signs:
not specified
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
Changes in serum composition
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Description (incidence and severity):
hepatitis, diffuse hepatocellular necrosis
Histopathological findings: neoplastic:
not specified
Details on results:
TDLo: 91 g/kg bw
The numerical dose data is a cumulative amount over the duration of the study.

Effect levels

open allclose all
Dose descriptor:
dose level: TDL0
Effect level:
91 000 mg/kg bw (total dose)
Based on:
test mat.
not specified
Dose descriptor:
dose level: TDL0
Effect level:
500 mg/kg bw/day (nominal)
Based on:
not specified
not specified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

The lowest toxic dose identified was 91 mg/kg bw/day.
Executive summary:

The repeated oral toxicity of ursodeoxycholic acid has been evaluated in a 26-week study of 1987. The lowest toxic dose identified was 91 mg/kg bw/day. Observed effects were: gastrointestinal hypermotility, diarrhea, hepatitis and diffuse hepatocellular necrosis, and changes in serum composition.