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EC number: 203-532-3 | CAS number: 107-92-6
Toxicity to reproduction: other studies
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:
- 1 996
- 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
- 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
Constituent 1
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
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.
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