Hazard 4 P 3 B 0 T 1 Risk Low
The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T are from Fass.se. The risk is from the report Goopoint 2019.
Fass environmental information for Aerius (desloratadine) (downloade 2019-11-28).
Persistence: "Desloratadine is hydrolytically stable with greater than 90% of the initial concentrations remaining after 5 days at 50°C. It has a half-life of greater than 1 year at 25°C (FDA 3.09). Desloratadine is not considered degradable, thus the phrase “desloratadine is potentially persistent” is chosen."
Bioaccumulation: "Log Kow = 1.24 at pH 7."
Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for green algae (Pseudokirchneriella subcapitata) 360 mikrog/L.
PEC/PNEC is based on sales data in Sweden in year 2016. PEC/PNEC = 0.0014 which gives the risk insignificant.
Desloratadine has been detected in treated wastewater in concentrations up to 15 ng/L and in surface water 1.1 ng/L in Region Stockholm 2018.
Report Pharmaceutial residues in the Stockholm aquatic environment. Desloratadine has been detected in treated wastewater up to 12 ng/L and in sludge up to 0.048 mg/kg DM (dry mass).
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