Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The original study report is not available, but the LD50 value is reported by a well recognized toxicological database: RTECS.

Data source

Reference
Reference Type:
secondary source
Title:
No information
Year:
1987
Bibliographic source:
BCFAAI Bollettino Chimico Farmaceutico. (Societa Editoriale Farmaceutica, Milan, Italy). 126,282. Available from RTECS database.

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
No details on the followed guideline have been reported.

Test material

Constituent 1
Reference substance name:
Ursodeoxycholic acid
EC Number:
204-879-3
EC Name:
Ursodeoxycholic acid
Cas Number:
128-13-2
IUPAC Name:
3,7-dihydroxycholan-24-oic acid

Test animals

Species:
rabbit

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
not specified
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
not specified

Applicant's summary and conclusion

Conclusions:
Subcutaneous LD50 in rabbits: > 2000 mg/kg bw.
Executive summary:

The reported LD50 in rabbits by subcutaneous route of administration is higher than 2000 mg/kg bw.