Registration Dossier
Registration Dossier
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EC number: 686-786-1 | CAS number: 84449-90-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
- in rabbit study, abortion and a low rate of fetal heart anormalities occurred at doses 0.1 mg/kg; hydrocephaly was observed in foetuses at doses 10 mg/kg(*).
- in rat studies, retardation of fetal developmental and developmental abnormalities occurred at doses 1 mg/kg(*).
- study in male rats at the dose up to 100 mg/kg/day for at least 2 week did not affect sperm production or quality, or reproductive performance. In female rats at doses of 0.1 to 10 mg/kg/day raloxifene disrupted estrous cycles and inhibited ovulation. These effects were reversible. (**)
FDA Category X: Contraindicated in Pregnancy (studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits). .
It is not known whether raloxifene is excreted in human milk. Its clinical use, therefore, cannot be recommended in breast-feeding women. Raloxifene may affect the development of the baby. (*, **)
* EMA report, Raloxifene hydrochloride. Summary of product characteristics. EMEA/H/C/001075 -IA/0012/G. Date update: 01-09-2014
** FDA label Initial U.S. Approval: 1997. Revised: 9/2014
Justification for classification or non-classification
Additional information
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