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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
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:
Unnamed
Year:
1975

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 material form:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

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:
Males: 1 day pre-mating
Females: from day 15 to day 22 of pregnancy
Lacting females: 21 days post-birth
Frequency of treatment:
No data
Details on study schedule:
No data
No. of animals per sex per dose:
No data

Results and discussion

Results: P0 (first parental generation)

Details on results (P0)

TDLo: 100 mg/kg bw for parent males.
TDLo: 3480 mg/kg bw for parent females.
The numerical dose data is a cumulative amount over the duration of the study.

Effect levels (P0)

open allclose all
Dose descriptor:
other: TDLo
Effect level:
100 mg/kg bw (total dose)
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: Fetal death. The total dose amount that was administered to the exposed parent (male for 1 day) is given.
Remarks on result:
other: Generation: fetus (migrated information)
Dose descriptor:
other: TDLo
Effect level:
3 480 mg/kg bw (total dose)
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: Effects on Newborn: Growth statistics (e.g., reduced weight gain). The total dose amount that was administered to the exposed parent (female 15-22 days pregnancy and 21 days post-birth) is given.
Remarks on result:
other: Generation: newborn (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The TDLo for fetol death of chenodeoxycholic acid is 100 mg/kg bw (total dose) for parent males and 3480 mg/kg bw (total dose) for parent females.
Executive summary:

After one oral administration of chenodeoxycholic acid to males per-mating, the TDLo for fetal death is 100 mg/bw (total dose) for parent males, while after oral administration to pregnant rats from day 9 to day 14 of pregnancy, and after 21 days post-birth, the TDLo for effects on newborn (growth statistics, like reduced weight gain) is 3480 mg/kg bw (total dose).