Carbidopa
Summary
Hazard 5* P 3* B 0 T 2* Risk Cannot be excluded
The T-value in the score for hazard refers to acute toxicity. Underlying data for P, B, T and risk are from Fass. Underlying value for B is also supported by the assessment report.
Assessment report
Assessment report for Numient (carbidopa, levodopa) 24 September 2015, EMA/CHMP/672104/2015.
Hazard
Persistence: No data.
Bioaccumulation OECD 107: log Pow of -1.92 ± 0.02.
Toxicity: No data.
Risk
PEC surfacewater, 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).
Fass environmental information
Fass environmental information for Sinemet (carbidopa, levodopa) (downloaded 2018-11-19).
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”."
Author: Health and Medical Care Administration, Region Stockholm