Itraconazole

Summary

Persistence. Itraconazole is potentially persistent.

Bioaccumulation. Itraconazole has high potential for bioaccumulation.

Toxicity. Itraconazole has low acute toxicity.

Risk. The use of itraconazole (sales data Sweden 2022) has been considered to result in insignificant environmental risk.

This summary information comes from fass.se.

Detailed information

Fass environmental information

Fass environmental information for Sporanox (itraconazole) from Janssen-Cilag (retrieved on 2025-07-09).

Hazard

Persistence: Itraconazole is not readily biodegradable based on a 28-day manometric respirometry test. Result: Itraconazole is potentially persistent.

Bioaccumulation: Itraconazole has a BCF of 3339 at pH 7.4, indicating a high potential for bioaccumulation.

Toxicity: There are data for 3 trophic levels, EC₅₀ > 1000 mg/L. Comment: Values reported as greater than are not according to the guidelines. The actual value may be lower.

Risk

PEC/PNEC is based on sales data in Sweden in year 2022.

PEC = 0.0021893285 microg/L.

PNEC = EC₅₀, > 1000000 microg/L/1000 (Assessment Factor (AF) for 3 acute studies) = 1000 microg/L.

PEC/PNEC = 0.000002189 which gives the risk insignificant.

Author: Health and Medical Care Administration, Region Stockholm