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Clopidogrel

Hazard 1 P 0 B 0 T 1 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B, T and risk are from Fass.

Assessment report

Below is information about clopidogrel from DuoCover's (clopidogrel, acetylsalicylic acid) assessment report 17 December 2009 Doc. Ref: EMA/CHMP/195986/2010, EMEA/H/C/001144.

"The submitted environmental risk assessment (ERA) includes a phase II tier A analysis. However, the ERA Phase II tier A analyses for clopidogrel have not been completed. The adsorption/desorption study (OECD106) submitted with the Applicant`s responses to the CHMP D120 LOQ (List of Questions) indicate that clopidogrel is not expected to pose a risk to the terrestrial compartment. The aerobic transformation study in aquatic sediment system (OECD308), also submitted with the Applicant`s responses to the CHMP D120 LOQ, indicates the need to perform a sediment organism toxicity test. The applicant commits to submit an updated ERA that includes the ongoing and agreed studies, namely: the log Kow determination and if required a bioconcentration test (OECD 305), the repetition of the activated sludge respiration inhibition test (OECD 209) and the consequent revision of the PEC/PNEC ratio, and the sediment organism toxicity test. The commitment includes identifying the metabolite (transformation product > 10% as well as in water as in sediment, detected in chromatography region 4) as requested in OECD guideline 308. This was acceptable to CHMP." Ingen ytterligare information har återfunnits på EMAs webbplats.

Fass environmental information

Fass environmental information for Plavix (clopidogrel) (downloaded 2018-10-30).

Hazard

Persistence OECD 308: "DT50total system = 7.5 (sediment 1) - 13.5 (sediment 2) days; DT50water = 7.2 (sediment 1) - 8.1 (sediment 2) days."

Bioaccumulation: Log Pow = 3.76 at pH 7.

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas) 310 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2016. PEC/PNEC = 0.0108 which gives the risk insignificant.

Author: The Pharmaceutical unit of Region Stockholm