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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Remarks:
RTECS database

Data source

Reference
Reference Type:
review article or handbook
Title:
No information
Year:
1975
Bibliographic source:
Kiso to Rinsho. Clinical Report. (Yubunsha Co., Ltd., 1-5, Kanda Suda-Cho, Chiyoda-ku, KS Bldg., Tokyo 101, Japan), 9, 3223

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
not specified.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Ursodeoxycholic acid
EC Number:
204-879-3
EC Name:
Ursodeoxycholic acid
Cas Number:
128-13-2
Molecular formula:
C24H40O4
IUPAC Name:
3,7-dihydroxycholan-24-oic acid

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Type of inhalation exposure (if applicable):
other: not applicable
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
From day 7 to day 12 of pregnancy.

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Remarks on result:
not measured/tested

Results: F1 generation

Effect levels (F1)

Dose descriptor:
other: TDLo
Generation:
F1
Effect level:
9 000 mg/kg bw (total dose)
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: Effects on Embryo or Fetus. Fetotoxicity (except fetal death) in presence of maternal effects. The numerical dose data is a cumulative amount over the duration of the study.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The TDLo for fetotoxicity of ursodeoxycholic acid is 9 g/kg bw (total dose).
Executive summary:

After oral administration of ursodeoxycholic acid to pregnant mice from day 7 to day 12 of pregnancy, the TDLo for fetotoxicity is 9 g/kg bw (total dose), in presence of maternal effects.