Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 611-193-1 | CAS number: 54739-18-3
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- not specified
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- Fluvoxamine Base provides the pharmacologic and toxicological propierties of this compound.
Maleate counterion is pharmacologically acceptable and not dangerous.
Thus, Fluvoxamine Base classification is based on Fluvoxamine Maleate.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- According to studies for Fluvoxamine maleate there is no evidenceof fertility impariment. Adverse effects were only seen at high doses in animal studies.
Avoid contact during pregnancy/while nursing.
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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