Registration Dossier
Registration Dossier
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EC number: 618-965-7 | CAS number: 937203-35-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Carbidopa was positive in the Ames test in the presence and absence of metabolic activation, was mutagenic in the in vitro mouse lymphoma and thymidine kinase assay in the absence of metabolic activation, and was negative in the in vivo mouse micronucleus test.
Source:www.drugs.com
Short description of key information:
Benzenepropanoic acid, α-hydrazino-3,4-dimethoxy-α-methyl-, (S)- is structurally analogue with the final API Carbidopa, CAS 38821-49-7 (monohydrate), CAS 28860 -95 -9 (anhydrous).
Endpoint Conclusion: Adverse effect observed (positive)
Justification for classification or non-classification
On the basis of the above consideration on the entire genotoxicity assessment of the structurally analogue API,
according the Regulation (EC) no.1272/2008 (EU Regulation on Classification, Labelling and Packaging of substances and mixtures), it can be concluded that the substance is suspected of causing genetic defects.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.
