Registration Dossier
Registration Dossier
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EC number: 601-490-4 | CAS number: 117704-25-3
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Under the conditions of the reproductive study in rats, the dams and their fetuses were exposed to similar concentrations of the unchanged drug. However, very little drug was found in the amniotic fluid.
Under the conditions of the reproductive study in mice, the dams were exposed to the unchanged drug. The concentrations in fetal homogenates and amniotic fluid, though lower than those seen in maternal plasma, indicate exposure of the fetuses to the drug.
Under the conditions of the reproductive study in rabbits, the dams were exposed to long-lasting concentrations of the unchanged drug.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Pharmacokinetics assays on rat, mouse and rabbit are available within reproductive studies (Kessedjian, 1988 and 1989).
Under the conditions of the reproductive study in rats, the dams and their fetuses were exposed to similar concentrations of the unchanged drug. However, very little drug was found in the amniotic fluid.
Under the conditions of the reproductive study in mice, the dams were exposed to the unchanged drug. The concentrations in fetal homogenates and amniotic fluid, though lower than those seen in maternal plasma, indicate exposure of the fetuses to the drug.
Under the conditions of the reproductive study in rabbits, the dams were exposed to long-lasting concentrations of the unchanged drug.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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