Cilastatin
Summary
Environmental Information
Persistence. Cilastatin is degraded in the environment.
Bioaccumulation. Cilastatin has low potential for bioaccumulation.
Toxicity. Cilastatin has low chronic toxicity.
Risk. The use of cilastatin (sales data Sweden 2019) 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 cilastatin from Tienam (cilastatin, imipenem) from MSD (downloaded 2023-12-19).
Hazard
Persistence: "Since half-life < 32 days for total system, cilastatin is degraded in the environment."
Bioaccumulation: Log Kow = -3.53 at pH 7.
Toxicity: There are data for 3 trophic levels, most sensitive fish, fathead minnow (Pimephales promelas) EC10 32 d (growth) > 9.9 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 2019. PEC/PNEC = 0.0000056 which gives the risk insignificant.
Assessment report
Assessment report for Recarbrio (cilastatin, imipenem, relecaktam) 15 October 2020, EMA/CHMP/538608/2020.
"The environmental risk assessment for imipenem and cilastatin are on-going and will be submitted in 4Q 2020. [...] The CHMP reiterated that the Environmental risk assessment of imipenem and cilastatin needs to be submitted no later than the end of Q4 2020." No such information has been found when searching the EMA website (2023-12-19).
Author: Health and Medical Care Administration, Region Stockholm