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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
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:
1978
Bibliographic source:
Oyo Yakuri Pharmacometrics. (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-91, Japan) V. 16,51

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
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
Details on mating procedure:
Not available
Duration of treatment / exposure:
Females: fom day 6 to day 18 of pregnancy.
Frequency of treatment:
Not available
Duration of test:
Not available
No. of animals per sex per dose:
Not available

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no data

Effect levels (maternal animals)

Dose descriptor:
other: TDLo
Effect level:
260 mg/kg bw (total dose)
Based on:
no data
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Details on embryotoxic / teratogenic effects:
Specific Developmental Abnormalities. Musculoskeletal system.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The TDLo for developmental effects of chenodeoxycholic acid in rabbits isre 260 mg/kg bw (total dose).
Executive summary:

After oral administration of chenodeoxycholic acid to female rabbits from day 6 to day 18 of pregnancy, the TDLo for developmental effects is 260 mg/kg bw (total dose).