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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The LD50 value has been obtained by a secondary source (RTECS database) and it was not possible to assess the quality of the original source.

Data source

Reference
Reference Type:
secondary source
Title:
No information
Author:
Bollettino Chimico Farmaceutico
Year:
1987
Bibliographic source:
(Societa Editoriale Farmaceutica, Via Ausonio 12, 20123 Milan, Italy), 126,282. Available from RTECS database.

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Only the LD50 value for acute oral toxicity in rats is reported.
GLP compliance:
not specified
Test type:
other: no data are available

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:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 600 mg/kg bw
Based on:
not specified

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 in rats is 4600 mg/kg bw.
Executive summary:

After oral administration to rats, the acute LD50 for the similar substance ursodeoxycholic acid is 4600 mg/kg bw.