Irinotecan
Summary
Persistence. Irionotecan considered to be slowly degraded in the environment.
Bioaccumulation. Irionotecan has low potential for bioaccumulation.
Toxicity. Irionotecan has very high acute toxicity.
Risk. The use of irionotecan (sales data Sweden 2022) has been considered to result in insignificant environmental risk.
This summary information comes from fass.se. Comparable data on bioaccumulation are also available in the assessment reports.
Detailed information
Fass environmental information
Fass environmental information for Irinotecan Fresenius Kabi (retrieved on 2025-07-09).
Hazard
Persistence: Environmental data indicate that irinotecan is slowly degraded in the environment. The predicted biodegradation half-life is approximately 96 days. Hydrolysis is not a major degradation pathway, while photolysis is significant at neutral and basic pH, with over 90% degradation within 1 hour. At acidic pH (4–5), photolytic degradation is limited. Overall, irinotecan is considered to be slowly degradable in the environment.
Bioaccumulation: The bioconcentration factor is low (7.19 L/kg), indicating a low potential for bioaccumulation.
Acute toxicity: There are data for 3 trophic levels, most sensitive crustacean LC50 23 microg/L.
Risk
PEC/PNEC is based on sales data in Sweden in year 2022.
PEC = 0.000727 microg/L.
PNEC = Lowest NOEC, 23 microg/L/1000 (Assessment Factor (AF) for 3 acute studies) = 0.023 microg/L
PEC/PNEC = 0.0316 which gives the risk insignificant.
Assessment report Onivyde 2016
Assessment report for Onivyde pegylated liposomal (irinotecan), 21 July 2016, EMA/CHMP/589179/2016.
Hazard
Persistence: No data.
Bioaccumulation: Log Dow values according to OECD 107 indicate low bioaccumulation potential: –2.03 at pH 4, 0.27 at pH 7, and –0.81 at pH 9.
Toxicity: No data.
Risk
PECsurface water, default or refined (e.g. prevalence data, literature): 6.4·10⁻⁴ µg/L The value is below the threshold of < 0.01 µg/L.
Comment
Irinotecan 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 irinotecan (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.
Assessment report Onivyde pegylated liposomal 2024
Assessment report for Onivyde pegylated liposomal, type II variation, 21 March 2024, EMA/162308/2024.
The extended indication for Onivyde pegylated liposomal is expected to increase use and environmental exposure. A refined PECsurface water value (0.00113 µg/L) was calculated using prevalence data from Hungary. The value is below the threshold requiring further ERA. Irinotecan is not expected to pose an environmental risk.
References
- Fass för vårdpersonal.
- European Medicines Agency. European public assessment report (EPAR) for Onivyde (irinotecan), 21 July 2016, EMA/CHMP/589179/2016.
- European Medicines Agency. European public assessment report (EPAR) for Onivyde pegylated liposomal, type II variation, 21 March 2024, EMA/162308/2024.
Author: Health and Medical Care Administration, Region Stockholm