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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

sub-chronic toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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
Reference substance name:
Ursodeoxycholic acid
EC Number:
EC Name:
Ursodeoxycholic acid
Cas Number:
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.