Registration Dossier
Registration Dossier
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EC number: 200-074-6 | CAS number: 50-98-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Two non-standard test were available, which do not allow a conclusion on reprotoxic effects of the test substance.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Toxicity to reproduction: other studies
Additional information
In a teratogenicity study (Kanai, 1986) pregnant rats were injected intraperitoneally on day 9, 10 or 11 of gestation with a single dose of 0.1, 1.0, 10 or 50 mg/kg bw ephedrine to examine teratogenicity in the cardiovascular system. 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.
The teratogenic effec of Ephedrine was on cardiac development in chick embyos was examined by dropping the test item (single dose of 0.51 mg/mL) onto the surface of the chorioallantoic membrane of 2, 3, 4 and 5-day-old chick embryos (Matsuoka, 1992). Following treatment, the eggs were re-incubated . Of these 900 embryos, 10 groups were sacrificed daily (from 10 to 21 days of incubation) and fixed with Carnoy fixative (60 % alcohol, 30 % chloroform and 10 % acetic acid) . Dead or dying embryos were also harvested each day. After 24 hours' fixation, embryos were dissected under a stereomicroscope, and cardiovascular or extracardiac malformations were compared. No aneurysms were induced. A slit-like small ventricular septal defect was found in 9.5 % of the chick embryos and 9.1 % in the control group. This effect was considered as not being adverse and treatment-related.
Justification for classification or non-classification
Based on the available data, no conclusion on classification and labelling can be done.
Additional information
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