Gefitinib
Summary
Persistence. Gefitinib is potentially persistent.
Bioaccumulation. Gefitinib has low potential for bioaccumulation.
Toxicity. Gefitinib has high chronic toxicity.
Risk. The use of gefitinib (sales data Sweden 2022) has been considered to result in insignificant environmental risk.
This summary information comes from fass.se.
Detailed information
Assessment report
Assessment report for Iressa (gefitinib), Doc.Ref.: EMEA/CHMP/563746/2008.
"An environmental risk assessment has been performed, and there are no indications that gefitinib pose a significant risk to the environment." No data are presented.
Fass environmental information
Fass environmental information for Iressa from AstraZeneca (retrieved on 2025-07-07).
Hazard
Persistence: Biodegradation of Gefitinib. Gefitinib is not readily biodegradable (< 5 % in 28 days, OECD 301F) and is hydrolytically stable (< 10 % hydrolysis, OECD 111). In sediment-water systems (OECD 308), it rapidly partitioned into sediment, where it remained largely unchanged and non-bioavailable. No significant degradation or mineralization was observed. Based on these findings, gefitinib is considered potentially persistent.
Bioaccumulation: Bioaccumulation of Gefitinib. Gefitinib is an ionisable compound with pKa values of 5.42 and 7.24. The octanol/water partition coefficient (Log Pow) was measured as 4.15 at pH 9 (OECD 107). Based on OECD 107 data and a calculated Log Dow of 2.15 at pH 7. Gefitinib is considered to have low potential for bioaccumulation.
Toxicity: There are data for 3 trophic levels, most sensitive fish NOEC (Pimephales promelas) NOEC 32 microg/L.
Risk
PEC/PNEC is based on sales data in Sweden in year 2022. PEC/PNEC = 0.00002 which gives the risk insignificant.
Author: Health and Medical Care Administration, Region Stockholm