This summary information comes from Fass. The risk is also confirmed by the assessment from Goodpoint.
Persistence. Ciprofloxacin is potentially persistent.
Bioaccumulation. Ciprofloxacin has low potential for bioaccumulationn.
Toxicity. Ciprofloxacin has a very high chronic toxicity.
Risk. The use of ciprofloxacin (sales data Sweden 2019) has been judged to entail a risk high of environmental impact.
Ciprofloxacin has different classifications on fass.se. According to Lif (the trade association for the research-based pharmaceutical industry in Sweden) the various pharmaceutical companies compile environmental information for their active substances based on internal studies and published data. Based on data, which may thus differ between different pharmaceutical companies, the companies assess the environmental risk with guidance from “Environmental classification of pharmaceuticals at www.fass.se – Guidance for pharmaceutical companies 2012”. The Swedish Environmental Institute (IVL) reviews the assessment but does not have the task of coordinating/harmonizing environmental information from different pharmaceutical companies for the same active substance.
Persistence: "Not readily degradable (28 days; Measurement of biological oxygen demand according to the guidelines published by OECD) (Halling-Sørensen, 2000). Ciprofloxacin is not readily biodegradable. Therefore, the phrase 'Ciprofloxacin is potentially persistent' is chosen."
Bioaccumulation: "Log Kow = 1.24 (estimated with ACD Log P software (Advanced Chemical Development, Toronto, Canada (Halling-Sørensen, 2000)."
Acute toxicity: There are data for 3 trophic levels, most sensitive cyanobacteria Mycrocystis aeruginosa EC50 = 5 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2019. PEC/PNEC = 86 which gives the risk high.
Persistence: "Biotic degradation. In a study on ready biodegradation according to OECD TG 301F ciprofloxacin was not degraded as 0 % biodegradation was observed at day 28. Abiotic degradation. Hydrolysis: In a study according to OECD TG 111 ciprofloxacin was hydrolytically stable at pH 4, 7, and 9 and at 50 °C. As no biotic or abiotic degradability of ciprofloxacin was observed the following phrase applies: “Ciprofloxacin is potentially persistent."
Bioaccumulation: "Log K of 1.1 at pH 2.5 (< 1 at pH 5.5-7) for ciprofloxacin (OECD TG 121)."
Chronic toxicity: There are data for 3 trophic levels, most sensitive fish (Pimephales promelas) NOEC 29 d (development, survival and length) = 0.89 µg/L (OECD TG 210).
PEC/PNEC is based on sales data in Sweden in year 2019. PEC/PNEC = 4.22 which gives the risk moderate.
Due to the risk of ecotoxicity of ciprofloxacin in water, the substance is monitored within the framework of EU water legislation to "improve knowledge of the occurrence and spread of antimicrobials in the environment".
Ciprofloxacin is among special pollutants in the Swedish Agency for Marine and Water Management regulation HVMFS 2019:25.
Measurements have shown that ciprofloxacin is present in the Swedish wastewater treatment plants at levels posing risk of selection of resistant bacteria.
The substance is included in Region Stockholm's table of pharmaceuticals with risk for negative environmental impact according to the environmental programme 2017–2021. Ciprofloxacin has been detected in treated wastewater in Region Stockholm.
Studies have shown that even low concentrations of antibiotics in the environment may trigger antibiotic resistance and therefore measures should be taken to ensure that as little as possible ends up in our environment.
Ciprofloxacin is recommended in the Wise list. Environmental classification of pharmaceuticals is taken into consideration, sometimes with other environmental aspects, when selecting pharmaceuticals for the Wise list. When comparable pharmaceuticals are equivalent to medical effects, safety and pharmaceutical efficacy, environmental impact and price are considered.
Concrete proposals on how to work to reduce emissions of environmentally harmful pharmaceuticals on the list have been developed in close cooperation with the Stockholm Drug and Therapeutics Committee's expert groups. The action proposals were developed from an environmental perspective. The patient's best always goes first and several pharmaceuticals on the list are also included in the Wise list. However, for such pharmaceuticals, there may be measures that could reduce the environmental impact.
Concrete proposal for ciprofloxacin
Author: Health and Medical Care Administration, Region Stockholm