Ebastine
Summary
Persistence. The potential for persistence of ebastine cannot be excluded, due to lack of data.
Bioaccumulation. Ebastine has high potential for bioaccumulation.
Toxicity. It cannot be excluded that ebastine is toxic, as data are lacking.
Risk. Low environmental risk, although the assessment remains uncertain due to insufficient efficacy data.
This summary information comes from fass.se. The risk originates from the report by Goodpoint.
Detailed information
Fass environmental information
Fass environmental information for Kestine (ebastine) from Almirall (downloaded 2019-11-28).
Hazard
Persistence: No data.
Bioaccumulation: Log Po/w = 4.1 (method and pH unknown). "Since log P is > 4, ebastine has high potential for bioaccumulation."
Toxicity: No data.
Risk
Risk of environmental impact of ebastine cannot be excluded, since no ecotoxicity data is available.
Report Goodpoint 2019
Comparative assessment of environmental risk when using the antihistamines desloratadine, cetirizine, loratadine, ebastine, clemastine and fexofenadine from a Swedish perspective (Report Goodpoint 2019).
Summary assessment based on (expected) water exposure in relation to toxicity and interaction with targets. Use of clemastine (Tavegyl) is considered to pose a risk of impact on aquatic organisms. It is supported by the fact that measured concentrations in the environment are in good agreement with predicted levels, these levels, although very low, are considered to be able to accumulate in fish to therapeutic concentrations given its high fat solubility (for which there is a reasonable consensus assessment), and finally have levels above Cmax been detected in wild fish. Studies on effects on aquatic organisms are lacking for clemastine, so the assessment is based entirely on the above. Thus, what kind of pharmacological effect can be expected from clemastine through its effect on the histamine receptors, and how severe these are, has not been investigated. The risk of impact is significantly lower, but not negligible, for fexofenadine. The other studied antihistamines pose a low risk based on expected exposure and the likelihood of accumulation in biota to near therapeutic concentrations, at the same time the assessment is uncertain due to insufficient efficacy data. An exchange of clemastine with one of the other studied antihistamines is recommended from an environmental point of view.
Author: Health and Medical Care Administration, Region Stockholm
