Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Unsuitable test system for the assessment of human reproductive toxicity

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: ASTM: Standard guide for conducting the Frog Embryo Teratogenesis Assay: Xenopus (FETAX), American Society for Testing and Materials E1439-91. Philiadelphia: ASTM Special Publications, 1991
Principles of method if other than guideline:
45 caboxylic acids were tested in the FETAX test. The results were subjected to quantitative structure activity relationship (QSAR) analyses and computer-automated structure evaluation (CASE)
GLP compliance:
no
Type of method:
in vivo

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyric acid
EC Number:
203-532-3
EC Name:
Butyric acid
Cas Number:
107-92-6
Molecular formula:
C4H8O2
IUPAC Name:
butyric acid
Details on test material:
- Name of test material (as cited in study report): butyric acid
- Analytical purity: ≥ 98% (test substance purchased from Aldrich Chemicals Co., Milwaukee, Wi, USA or from Sigma Chemical Co., St. Louis, MO, USA)
- Impurities (identity and concentrations): no data
- Storage condition of test material: no data

Test animals

Species:
other: frog
Strain:
other: Xenopus laevis

Administration / exposure

Route of administration:
other: test substance was added to the test vessels from a stock solution
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
96 h
Duration of test:
96 h
Doses / concentrations
Remarks:
Doses / Concentrations:
8 to 12 graduate concentrations, individual concentrations not spezified
Basis:

No. of animals per sex per dose:
25 per test, three separate tests
Control animals:
yes, concurrent no treatment
Statistics:
LC50 and EC 50 were calculated using probit analysis.

Results and discussion

Effect levels

open allclose all
Dose descriptor:
other: EC50
Effect level:
421.6 other: mg/L
Based on:
test mat.
Basis for effect level:
other: malformation of frog embryos; 95% CL: 397 - 447 mg/L
Dose descriptor:
other: LC50
Effect level:
3 559 other: mg/L
Based on:
test mat.
Basis for effect level:
other: Lethality of frog embryos; 95% CL 3281 - 3811 mg/L

Observed effects

Lethality and malformation (not further spezified) of frog embryos

Any other information on results incl. tables

No information on controls and validity of the test.

Applicant's summary and conclusion

Conclusions:
In a frog embryo teratogenesis assay performed according to a standard guide of ASTM (E1439-91) using butyric acid as test substance, a LC50 of 3559 mg/L and an EC50 (malformation) of 421 mg/L was determined. The DHI (Developmental Hazard Index) calculated to 8.4 indicating that the effective dose of butyric acid causing malformation was about 8-fold lower than the dose causing lethality.