Galantamine
Summary
This summary information on persistence, biockumulation and toxicity comes from Fass. The risk comes from the Goodpoint report.
Persistence. Galantamine is potentially persistent.
Bioaccumulation. It cannot be excluded that galantamine bioaccumulates, due to the lack of data.
Toxicity. Galantamine has very high acute toxicity.
Risk. The environmental risk is very low for galantamine from a Swedish perspective.
Detailed information
Fass environmental information
Fass environmental information for Reminyl (galantamine) from Janssen (downloaded 2021-04-12).
Hazard
Persistence: "Galantamine Hydrobromide is not readily biodegradable in a biodegradability test according to OECD No. 301 F: “Manometric respirometry test” [5]. On the basis of the titration results can be concluded that Galantamine Hydrobromide is not readily biodegradable, since the pass level of 60% was not reached after an exposure period of 28 days. Consequently, the medicine is potentially persistent."
Bioaccumulation: No data.
Acute toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) 440 microg/L.
Risk
PEC/PNEC is based on sales data in Sweden in year 2019. PEC/PNEC = 0.010444141 which gives the risk insignificant.
Report from Goodpoint 2020
Comparative assessment of environmental risk when using medicinal products in the treatment of Alzheimer's disease/dementia (memantine, donepezil, rivastigmine, galantamine) from a Swedish perspective.
All investigated substances are likely to occur in concentrations close to or below 20 ng/L in Swedish aquatic environments exposed to treated wastewater. The environmental risk is very low for galantamine and rivastigmine, based on expected water exposure in relation to both potential for bioconcentration and potency in humans (fish plasma model) as well as available ecotoxicological data. The environmental risk is also low for memantine, although the ecotoxicity information is more scarce. However, the use of donepezil is associated with a certain environmental risk. [...] The use of galantamine, rivastigmine and memantine is not considered to pose an environmental risk. There is an increased risk of donepezil, but due to the lack of ecotoxicity studies, the scientific support is not currently considered strong enough to recommend an exchange. Continued measurements of donepezil in treated wastewater are recommended together with measurements in exposed aquatic biota.
Author: Health and Medical Care Administration, Region Stockholm