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Rivaroxaban

Hazard 8 P 3 B 3 T 2 Risk Insignificant

Information

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

Assessment report

Assessment report for Xarelto (rivaroxaban) 22 September 2011, EMA/CHMP/301607/2011.

Hazard

Persistence: "DT50, whole system = 51.9 d (worst case) % shifting to sediment = 35,4."

Bioaccumulation: "On the basis of the correct octanol/water partition coefficient of log POW = 1.5, no study on bioaccumulation in fish (OECD 305) is required according to the ERA guideline CHMP/SWP/4447/00 (June 2006), because the trigger value for this study of log POW = 3 is not reached."

Toxicity: There are data for 2 trophic levels, most sensitive fish (Danio rerio) NOEC 86 microg/L.

Risk

"In conclusion, all remaining issues have been addressed and the Applicant ́s responses were considered acceptable. As a result, the data allow to conclude that ribaroxaban does not have a potential risk to the environment."

Fass environmental information

Fass environmental information for Xarelto from Bayer (downloaded 2019-10-14).

Hazard

Persistence: "The overall disappearance half-life from the system was between 30 and 60 days. Therefore, rivaroxaban can be classified: Rivaroxaban is slowly degraded in the environment."

Bioaccumulation: "Log Pow 4,2 (Shake flask method, non-GLP). Rivaroxaban has a high potential for bioaccumulation."

Toxicity: There are data for 3 trophic levels, most sensitive fish (Pimephales promelas) NOEC 86 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2015. PEC/PNEC = 0.0028 which gives the risk insignificant.

Author: The Pharmaceutical unit of Region Stockholm