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
Effects on fertility
Additional information
Carbidopa had no effect on the mating performance, fertility, or survival of the young when administered orally to rats at doses of 30, 60, or 120 mg/kg/day. The highest dose caused a moderate decrease in body weight gain in males.
There are no adequate and well-controlled studies with carbidopa in pregnant women. It has been reported from individual cases that levodopa crosses the human placental barrier, enters the fetus, and is metabolized. Carbidopa concentrations in fetal tissue appeared to be minimal. Carbidopa should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Carbidopa, at doses as high as 120 mg/kg/day, was without teratogenic effects in the mouse or rabbit.
Source DailyMed Current Medication Information - data on CARBIDOPA (CAS 38821-49-7)
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).
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 reproductive toxicant.
Additional information
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