Valganciclovir

Detailed information

Fass environmental information

Fass environmental information for Valcyte (valganciclovir) from Roche (retrieved on 2025-10-06). "Valganciclovir is a prodrug of ganciclovir with rapid, nearly quantitative metabolic ester hydrolysis, hence environmentally relevant data will only be listed for Ganciclovir."

Hazard

Persistence: "Ganciclovir/valganciclovir is not readily degradable. In sediment/water fate systems according to OECD 308 a DT₅₀ of 14–18 days (≤ 32 days) for the total system was observed. The parent compound (i.e. water and sediment extractions added together) compared to the total amount applied at the start of the study was < 15%. Moreover, a mineralisation of up to 69.5% was observed. The results of this study indicate that Ganciclovir / Valganciclovir is unlikely to persist in natural water-sediment systems. This justifies the phrase 'Ganciclovir / Valganciclovir is degraded in the environment.'"

Bioaccumulation: Log K_ow = -1.95 (average of pH 5 and 7, unionised, 25 °C) (FDA method 3.02, stirrring method).

Toxicity: There are data for 3 trophic levels, most sensitive fish (Pimephales promelas) NOEC 12 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2021.

PEC = 1.2 microg/L.

PNEC = Lowest NOEC, 12 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 1.2 microg/L.

PEC/PNEC = 0.008 which gives the risk insignificant.