Amikacin
Summary
Persistence. Amikacin is very persistent (vP).
Bioaccumulation. Amikacin has low potential for bioaccumulation.
Toxicity. Amikacin has very high chronic toxicity.
Risk. "Toxicity is reported as much lower as assessed in appropriately conducted studies as per OECD 210 and 211. PEC/PNEC comparisons do not indicate amikacin as posing a threat to the environment. However, due to the concern raised on the conduct of the OECD 201 study which was shown to be the most sensitive to the effects of amikacin, available data do not allow to conclude definitively on the potential risk of amikacin to the environment."
This summary information comes from assessment report for Arikayce liposomal (amikacin). Environmental information is missing on fass.se for amikacin (2023-10-24). It is voluntary for manufacturers to provide information on environmental impact on fass.se.
Detailed information
Assessment report
Assessment report for Arikayce liposomal (amikacin), 23 July 2020, EMA/473660/2020.
Hazard
Persistence: "DT50, whole system (12 ºC)= 2629 days, % shifting to sediment = 22.6 (OECD 308). Conclusion: Amikacin can be considered very persistent. % partitioning to sediment >10%, hence Phase IIb sediment toxicity study triggered % orgC 3.4 and 0.64 for Taunton and Weweantic river systems respectively."
Bioaccumulation: Log Kow < -2.00. "Conclusion: Below 4.5 threshold, no PBT screening warranted."
Toxicity: There are data for 3 trophic levels, most sensitive algae (class Cyanophyceae) NOEC 1.7 microg/L (OECD 201).
Risk
"Toxicity is reported as much lower as assessed in appropriately conducted studies as per OECD 210 and 211. PEC/PNEC comparisons do not indicate amikacin as posing a threat to the environment. However, due to the concern raised on the conduct of the OECD 201 study which was shown to be the most sensitive to the effects of amikacin, available data do not allow to conclude definitively on the potential risk of amikacin to the environment."
"The applicant has completed an ERA in line with the EMAs ‘Guideline on the environmental risk
assessment of medicinal products for human use’. In general, the ERA was conducted appropriately but the applicant was requested to repeat the completed OECD 201 study as it did not meet its predefined validity criteria and has committed to do so in post-authorisation." No such information has been found on the EMA website (2023-10-24).
Author: Health and Medical Care Administration, Region Stockholm