Ephedrine hydrochloride

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only abstract available (limited documentation) Deviating route of administration (intraperitoneally)

Data source

Reference

Reference Type:

publication

Title:

Cardiovascular teratogenicity of ephedrine in rats.

Author:

Kanai T.

Year:

1986

Bibliographic source:

TERATOLOGY 34:437-486 : Abstracts of Papers Presented at the Twenty-Sixth Annual Meeting of the Japanese Teratology Society Nagoya, Japan July 12-13, 1986

Materials and methods

Principles of method if other than guideline:

Pregnant rats were injected intraperitoneally on day 9, 10 or 11 of gestation with 0.1, 1.0, 10 or 50 mg/kg bw of ephedrine to examine teratogenicity in the cardiovascular system.

GLP compliance:

no

Type of method:

in vivo

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

- Name of test material: Ephedrine

Test animals

Species:

rat

Strain:

other: Isamichi

Administration / exposure

Route of administration:

intraperitoneal

Duration of treatment / exposure:

single dose exposure

Frequency of treatment:

Once, on day 9, 10 or 11 of gestation.

Duration of test:

9-11 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0.1 ; 1.0 ; 10 or 50 mg/kg bw
Basis:
nominal conc.

Details on study design:

Sacrifice of the animals was carried out on day 20 of gestation with removal of fetuses.

Results and discussion

Observed effects

107 out of 523 fetuses (20.5 %) demonstrated cardiovascular anomalies. The frequency of embryos with anomalies was dose-dependent, and was 8.1-26.9 % by the administration of 0.1 - 50 mg/kg bw ephedrine. There was no significant difference in the malformation rate among fetuses dosed on day 9, 10 or 11 of gestation. All of the cardiovascular malformations were ventricular septal defect, two of which were associated with overriding aorta (2/107 fetuses: 1.9 %). Extracardiac malformations were not observed in these fetuses.

Any other information on results incl. tables

In the second experiment, ephedrine concentration in the serum of dams and the whole body of fetuses was quantitatively analysed by gas chromatography in 10-day pregnant rats after injection with 50 mg/kg bw ephedrine. Concentrations of ephedrine in rat dam serum were 19.2, 7.2, 1.9 and 0 µg/mL at 1, 3, 6 and 12 hours after injection, respectively, and those in the fetus tissue were 34.9, 9.5, 2.7 and 0 µg/g bw 1, 3, 6 and 12 hours after injection, respectively.