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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: other routes
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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 detailes 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.