Etoposide

Detailed information

Comment on Fass environmental information

Etoposide has different classifications on fass.se. According to Lif (the trade association for the research-based pharmaceutical industry in Sweden) the various pharmaceutical companies compile environmental information for their active substances based on internal studies and published data. Based on data, which may thus differ between different pharmaceutical companies, the companies assess the environmental risk with guidance from “Environmental classification of pharmaceuticals at www.fass.se – Guidance for pharmaceutical companies 2012”. The Swedish Environmental Institute (IVL) reviews the assessment but does not have the task of coordinating/harmonizing environmental information from different pharmaceutical companies for the same active substance.

Fass environmental information Etoposid Fresenius Kabi

Fass environmental information for Etoposid Fresenius Kabi (etoposide) (retrieved on 2025-06-27).

Hazard

Persistence: Etoposide showed 40 % degradation over 7 days, but is not readily biodegradable according to BIOWIN QSAR predictions. Conclusion: Etoposide is potentially persistent in the environment.

Bioaccumulation: Log P = 0.60.

Toxicity: There are data for 3 trophic levels, most sensitive crustacean NOEC 98 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2021. PEC/PNEC = 0.0000592 which gives the risk insignificant. "The PNEC is based on the lowest EC₅₀/1000, where 1000 is the assessment factor used if acute data for 3 trophic levels is available. The EC₅₀ for growth inhibition in the algae Pseudokirchneriella subcapitata has been used for this calculation since it is the most sensitive of the tested species."

The interpretation is that chronic toxicity data are available for both crustaceans and algae.

PEC = 0.000745 μg/L.

PNEC = Lowest NOEC 98 microg/L/50 (Assessment Factor (AF) for 2 chronic studies) = 1.96 microg/L

PEC/PNEC = 0.00038 which also gives the risk insignificant.

Fass environmental information Eposin

Fass environmental information for Eposin (etoposide) from Teva (retrieved on 2025-06-27).

Hazard

Persistence: No data.

Bioaccumulation: Log P = 0.60.

Toxicity: No data.

Risk

PEC is based on sales data in Sweden in year 2021. PEC = 0.000731 μg/L. "According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of etoposid is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L."