Carbidopa
Summary
Persistence. It cannot be excluded that carbidopa is persistent, due to the lack of data.
Bioaccumulation. Carbidopa has low potential for bioaccumulation.
Toxicity. Carbidopa has high acute toxicity.
Risk. Risk of environmental impact of carbidopa cannot be excluded, since there is not sufficient ecotoxicity data available.
The data on hazard and risk are based on previous environmental information on fass.se. Environmental information is missing (2023-03-01). It is voluntary for manufacturers to provide information about environmental impact on fass.se. Underlying value for bioaccumulation is also supported by the assessment report for Numient (carbidopa, levodopa) which is withdrawn from use.
Detailed information
Fass environmental information
Fass environmental information for Sinemet (carbidopa, levodopa) from MSD (downloaded 2018-11-19). Sinemet from MSD has been withdrawn from use.
Hazard
Persistence: No data.
Bioaccumulation: Log Kow = - 0.13.
Acute toxicity: There is data for one trophic level, crustaceans (Daphnia magna) 35 300 microg/L.
Risk
"Based on limited data, the phrase chosen for carbidopa is “Risk of environmental impact of carbidopa cannot be excluded, since there is not sufficient ecotoxicity data available”."
General information about assessment reports
Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.
Assessment report
Assessment report for Numient (carbidopa, levodopa) 24 September 2015, EMA/CHMP/672104/2015. Numient has been withdrawn from use.
Hazard
Persistence: No data.
Bioaccumulation OECD 107: log Pow of -1.92 ± 0.02.
Toxicity: No data.
Risk
PECsurfacewater, refined = 0.80 microg/L, > 0.01 threshold. "Considering the clinical practice for treating Parkinson Disease patients, the CHMP agreed that the introduction of Numient would not lead to a significant increase in the levels of carbidopa currently prescribed in the EU. Therefore, the absence of a phase II environmental risk assessment for carbidopa was considered to be acceptable." No further previous information on carbidopa and environmental effects has been found on the EMA website(2018-11-19).
Author: Health and Medical Care Administration, Region Stockholm