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Edoxaban tosylate

Hazard 3 P 3 B 0 T 0 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

Assessment report for Lixiana (edoxaban) 23 April 2015, EMA/321083/2015.

Hazard

Persistence: DT50, water(20°C)= 1.1d, DT50, sediment (20°C) = 59.1d, DT50 sediment (12°C) = 126.1d, DT50, whole system (20°C) = 6.1d, % shifting to sediment = 60.7 (day 14) TP: D21-3231-0101 > 10%. Remarks: "P, significant shifting to the sediment, test on sediment organism is required."

Bioaccumulation: No data.

Toxicity: There are data for 2 trophic levels, most sensitive fish (Pimephales promelas) NOEC 2.32 mg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PEC = 0.3 microg/L

PNEC = Lowest NOEC, 2 320 microg/L/50 (Assessment Factor (AF) for 2 chronic studies) = 46.4 microg/L

PEC/PNEC = 0.00646 which gives the risk insignificant.

"In the context of the obligation of the MAH (Marketing Authorisation Holder ed. note) to take due account of technical and scientific progress, the CHMP recommends the following points to be addressed: (1) to provide an adsorption study for soils in accordance with OECD 106, (2) to submit a valid OECD 201 study for algae." No such information was found on EMA's website (2019-10-14). According to the Swedish Medical Products Agency, the company/MAH did not submit the requested studies and updated its nvironmental risk assessment (ERA) (2019-10-18).

Fass environmental information

Fass environmental information for Lixiana from MSD (downloaded 2019-10-14).

Hazard

Persistence: "Since half-life < 32 days for total system and >15% remaining as parent compound, the substance is slowly degraded in the environment."

Bioaccumulation: Log Kow = 1.7 at pH 8.

Chronic toxicity: There are data for 3 trophic levels, most sensitive fish (Pimephales promelas) NOEC 2.32 mg/L.

Risk

PPEC/PNEC is based on sales data in Sweden according to the information: "maximum estimated 5 year sales in Sweden, data blinded for confidentiality". PEC/PNEC = 0.00043 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm