Registration Dossier

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Remarks:
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
Reliability:
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
Reference Type:
secondary source
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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
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 9 to day 14 of pregnancy.

Results and discussion

Results: P0 (first parental animals)

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
Sex:
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

Conclusions:
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).