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Administrative data

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).

Key value for chemical safety assessment

Justification for classification or non-classification

On the basis of the above consideration on the structurally analogue API, according the Regulation (EC) no.1272/2008 (EU Regulation on Classification, Labelling and Packaging of substances and mixtures), the substance does not need to be classified as carcinogen.

Additional information

There were no significant differences between treated and control rats with respect to mortality or neoplasia in a 96-week study of carbidopa at oral doses of 25, 45, or 135 mg/kg/day. Source DailyMed Current Medication Information - data on CARBIDOPA (CAS 38821-49-7)