Registration Dossier

Diss Factsheets

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.