Hazard 3 P 3 B 0 T 0 Risk Insignificant
The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B, T and risk are from Fass.
Assessment report for Labazenit (budesonide, salmeterol) 27 June 2013, EMA/465765/2013.
Persistence: "The compound undergoes degradation in the environment and has no potential to accumulate in aquatic organisms (FASS.se-salmeterol)."
Bioaccumulation: "The Octanol/Water partition coefficient (LogKow) measured at 3 different pH conditions and 3 concentrations of the substance was found to be between 1.32 and 2.20 (Environmental Assessment, Serevent, NDA 20-692, Attachment 4). The value provided by the originator of salmeterol is LogKow = 2.2 at pH 7 (MSDS-2, Serevent Diskus). Also according to the ERA of salmeterol (Serevent) available on the website of the Swedish Medicine Agency (MPA) there is no significant bioaccumulation potential for salmeterol as its Octanol/Water partition coefficient was found to be 1.71 at pH 7, 2.06 at pH 5, 1.71 at pH 7, and 1.32 at pH 9."
Toxicity: No data.
"PECsurfacewater is 0.0005 μg/L. PECsurfacewater is below 0.01 μg/L, and thus a phase II assessment is not necessary. [---] As the PEC < 0.01 μg/l and the logKow <4.5, it can be assumed according to EMA guideline on the ERA of medicinal products for human use (CPMP/SWP/4447/00).that the medicinal product is unlikely to represent a risk for the environment following its prescribed usage in patients."
Fass environmental information for Seretide Diskus (fluticasone propionate, salmeterol) (downloaded 2019-02-13).
Persistence: "Biotic degradation, Ready degradability:No data. Inherent degradability: 50% degradation in 12.80 days (TAD 3.11). Soil metabolism: 29.9 to 49.9% degradation in 64 days (OECD 304). Abiotic degradation, Hydrolysis: 50% degradation > 1 year (TAD 3.09). Photolysis: No data. Salmeterol is not readily degradable but it is inherently primarily degradable in that removal of the parent API in the Sewage Treatment Plant is expected to a significant extent. The phrase “Salmeterol is potentially persistent” is thus chosen."
Bioaccumulation: Log Dow at pH 5 = 2.06, Log Dow at pH 7 = 1.71, Log Dow at pH 9 = 1.32.
Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Ceriodaphnia dubia) NOEC 8 days (reproduction) = 1 100 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2016. PEC/PNEC = 0.0000122 which gives the risk insignificant.
Salmeterol has been detected in waste water treatment plants in both incoming and outgoing water.
Author: Health and Medical Care Administration, Region Stockholm