Carbidopa

Information

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 P_ow 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 K_ow = - 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”."