Vinflunine
Summary
Persistence. It cannot be excluded that vinflunine is persistent, due to lack of data.
Bioaccumulation. Vinflunine has low potential for bioaccumulation.
Toxicity. It cannot be excluded that vinflunine is toxic, due to lack of data.
Risk. Risk of environmental impact of vinflunine cannot be excluded, due to the lack of environmental toxicity data.
This summary information is based on the 2009 assessment report for Javlor (vinflunine). See the section titled “Detailed Information” for further details. Environmental information is missing on fass.se for vinflunine (2025-09-24).
Detailed information
Assessment report
Assessment report for Javlor (vinflunine), Doc.Ref: EMEA/CHMP/370293/2009.
Hazard
Persistence: No data.
Bioaccumulation: "The Log Kow for vinflunine was below 4.5." However, no data are presented.
Toxicity: No data.
Risk
"The calculation of PECsw using this Fpen and a maximum daily dose of 320 mg/m2 would be equal to 0.000726 µg/L, i.e. a value far below the threshold of concern for environment, that is 0.01 µg/L." Fpen = fraction of the population receiving treatment.
Comment
Vinflunine has only undergone a phase I study in accordance with regulatory requirements for environmental risk assessments (Guideline on the environmental risk assessment of medicinal products for human use, EMEA/CHMP/SWP/4447/00 Rev. 1- Corr.) A phase I study includes data on bioaccumulation and an estimation of the environmental concentration of vinflunine (PECSurface water). If the specified threshold values are not exceeded, the company is not required to conduct a Phase II study, which includes data on toxicity, persistence, and risk assessment based on PEC/PNEC.
Author: Health and Medical Care Administration, Region Stockholm