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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

fertility, other
based on test type (migrated information)
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: Data have been obtained by a secondary source (RTECS database) and it was not possible to assess the quality of the original source.

Data source

Reference Type:
secondary source
No information
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
no guideline available
Principles of method if other than guideline:
Not specified.
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

not specified
not specified

Administration / exposure

Route of administration:
oral: unspecified
Type of inhalation exposure (if applicable):
other: not applicable
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
From day 9 to day 14 of pregnancy.

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

TDLo: 24 g/kg bw
The numerical dose data is a cumulative amount over the duration of the study.

Effect levels (P0)

Dose descriptor:
other: TDLo
Effect level:
24 000 mg/kg bw (total dose)
Based on:
not specified
not specified
Basis for effect level:
other: Effects on Embryo or Fetus. Fetotoxicity (except fetal death) The total dose amount that was administered to the exposed parent is given.
Remarks on result:
other: Generation: fetus (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

The TDLo for fetotoxicity of ursodeoxicholic acid is 24 g/kg bw (total dose).
Executive summary:

After oral administration of ursodeoxycholic acid to pregnant rats from day 9 to day 14 of pregnancy, the TDLo for fetotoxicity is 24g/kg bw (total dose).