Registration Dossier
Registration Dossier
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EC number: 219-542-6 | CAS number: 2458-08-4
Toxicity to reproduction
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:
- 1 975
- 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 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
Constituent 1
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 generation)
Details on results (P0)
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).
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