Registration Dossier
Registration Dossier
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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: 244-398-6 | CAS number: 21462-39-5
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from similar mixture/product
- Adequacy of study:
- other information
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Reproduction studies in rats and mice using oral and parenteral dosages of clindamycin up to 600 mg/kg daily (2.1 and 1.1 times, respectively, the maximum recommended human parenteral dosage or 3.2 and 1.6 times, respectively, the maximum human oral dosage on a mg/m sq basis) or subcutaneous doses of clindamycin up to 250 mg/kg daily (0.9 - 1.3 and 0.5 - 0.7 times, respectively, the maximum recommended human dosage on a mg/m sq basis) have not revealed evidence of harm to the fetus. While cleft palates were observed in fetuses in one mouse strain, this was considered to be a strain-specific effect since it was not observed in other mouse strains or in other species studied.
American Society of Health-System Pharmacists 2012; Drug Information 2012. Bethesda, MD. 2012, p. 473
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
