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Diss Factsheets

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1986
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Insufficient information for an assessment of reliability.

Data source

Reference
Reference Type:
publication
Title:
Pharmacologic Evaluation of Various Metabolites and Analogs of Valproic Acid: Teratogenic Potencies in Mice
Author:
Nau, H. and Löscher, W.
Year:
1986
Bibliographic source:
Nau, H. and Löscher, W. (1986). Pharmacologic Evaluation of Various Metabolites and Analogs of Valproic Acid: Teratogenic Potencies in Mice. Fundamental and Applied Toxicology, 6(4), 669 - 676.

Materials and methods

Principles of method if other than guideline:
Not available
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylbutyric acid
EC Number:
201-796-4
EC Name:
2-ethylbutyric acid
Cas Number:
88-09-5
Molecular formula:
C6H12O2
IUPAC Name:
2-ethylbutyric acid
Test material form:
not specified

Test animals

Species:
other: Mouse
Strain:
NMRI

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
water
Duration of treatment / exposure:
Injection on day 8 of gestation and examination on day 18 (10 day exposure period).
Frequency of treatment:
Single injection
Duration of test:
10 days
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Remarks:
Control
Dose / conc.:
600 mg/kg bw/day (nominal)
Remarks:
As sodium salt
Control animals:
yes

Examinations

Ovaries and uterine content:
Implantation sites
Fetal examinations:
Number of live fetuses, live fetus weight, examination for malformations, and mortality at birth.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Dead fetuses:
effects observed, treatment-related
Description (incidence and severity):
Number of live fetuses was reduced in the treated group.
Other effects:
no effects observed
Description (incidence and severity):
Embryolethality (%) was considered to be similar in control and exposed fetuses.

Effect levels (maternal animals)

Remarks on result:
other: Not available

Results (fetuses)

Fetal body weight changes:
effects observed, treatment-related
Description (incidence and severity):
Fetal weight was lower in the treated group.
Changes in litter size and weights:
effects observed, treatment-related
Description (incidence and severity):
Litters were smaller in the treated group.
External malformations:
effects observed, treatment-related
Description (incidence and severity):
Exencephaly (% of live fetuses) was higher in the treated group.

Effect levels (fetuses)

Remarks on result:
other: Not available

Overall developmental toxicity

Key result
Developmental effects observed:
yes
Lowest effective dose / conc.:
600 mg/kg bw/day (nominal)
Treatment related:
not specified
Relation to maternal toxicity:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

Applicant's summary and conclusion

Conclusions:
Exposure of female mice during day 8 of gestation to 600 mg/kg bw 2-ethylbutyric acid resulted in reduced live fetuses, fetal weight, and litter size and exencephaly in live fetuses. Embryolethality was considered to be similar in the control and treated group. 600 mg/kg bw can be regarded as the lowest effective dose, however, it should be noted that this was the only concentration tested in the study.