Naloxegol
Summary
Persistence. Naloxegol is potentially persistent.
Bioaccumulation. Naloxegol has low potential for bioaccumulation.
Toxicity. Naloxegol has low chronic toxicity.
Risk. The use of naloxegol (sales data Sweden 2019) has been considered to result in insignificant environmental risk.
This summary information comes from fass.se and assessment report. The risk is from fass.se.
Detailed information
Assessment report
Assessment report for Moventig (naloxegol), AstraZeneca AB, 25 September 2014, EMA/CHMP/738815/2014.
Hazard
Persistence: For naloxegol, the OECD 301B test showed only 0.7% mineralisation, indicating that the substance is not readily biodegradable. In the OECD 308 study on aerobic transformation in aquatic sediment systems, two sediments were examined: one with high organic matter (HOM) and one with low organic matter (LOM). The DT50 in water was 3.8 days for HOM and 2.6 days for LOM. For the whole system, DT50 could not be calculated, but the concentration decreased by 50% after 7 days in HOM and after 92 days in LOM. The highest Kd value was 120 (HOM), and no persistent breakdown products were observed.
Bioaccumulation: The bioaccumulation potential of naloxegol was assessed using the Shake Flask method according to OECD 107. At pH 5, the log Dow value was below –0.326; at pH 7, it was –0.643; and at pH 9, it reached 0.874. These findings indicate that the substance has a low bioaccumulation potential.
Chronic toxicity: There are data for 3 trophic levels, most sensitive fish (Fathead minnow) NOEC 2000 microg/L.
Risk
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PEC = 0.13 microg/L.
PNEC = Lowest NOEC, 2000 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = microg/L
PEC/PNEC = 0.00065 which gives the risk insignificant.
Fass environmental information
Fass environmental information for Moventig from Grunenthal Sweden AB (retrieved on 2025-11-26).
Hazard
Persistence: In addition to the above information contained in the assessment report on Moventig, the following data are also available: In an OECD 106 multi‑matrix adsorption study, mean Kd values were 19.5 L/kg in soil, 1039 L/kg in high organic sediment, 118 L/kg in low organic sediment, and 93 L/kg in post‑digester sludge. Naloxegol is reported as potentially persistent.
Bioaccumulation: OECD 107: pH 5 log Dow < -0.326, pH 7 log Dow = -0.643, pH 9 log Dow = 0.874.
Chronic toxicity: There are data for 3 trophic levels, most sensitive fish (Pimephales promelas) NOEC 2000 microg/L.
Risk
PEC/PNEC is based on sales data in Sweden in year 2019.
PEC = 0.000852 microg/L.
PNEC = Lowest NOEC, 2000 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 200 microg/L.
PEC/PNEC = 0.00000426 which gives the risk insignificant.
Author: Health and Medical Care Administration, Region Stockholm