Indacaterol
Summary
This summary information comes from assessment reports regarding the information on bioaccumulation, and from Fass.
Persistence. Indacaterol is potentially persistent.
Bioaccumulation. Indacaterol has low potential for bioaccumulation.
Toxicity. Indacaterol has low acute toxicity but see comment under "Detailed information".
Risk. The use of indacaterol (sales data Sweden 2018) has been considered to result in insignificant environmental risk.
Detailed information
General information about assessment reports
Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data can be found in the public investigation report (PAR/EPAR for medicinal product through a centralized procedure). Since the benefit/risk assessment for human medicinal products at present does not include environmental effects, an update of the environmental risk assessment is not required for renewals of marketing authorizations. There is thus no requirement for companies to stay informed about the development of their substances from an environmental point of view and consequently to update the environmental risk assessment as new data are published.
Assessment report
There are several assessment reports for different medicinal products containing indacaterol from Novartis with the same information. Reference is made here to the assessment report for Atectura Breezhaler (indacaterol, mometasone furoate), Novartis, 02 April 2020, EMA / 206547/2020.
Hazard
Persistence: No data.
Bioaccumulation: Log Kow -0.74 (at 20.1°C).
Toxicity: no data.
Risk
PECsurfacewater = 0.00075 microg/L. Conclusion: > 0.01 threshold (N).
"The log Kow for indacaterol was below (above here, ed. remark) the action limit for PBT screening and therefore phase II assessment for these agents was not required in the previous assessments."
Fass environmental information
Fass environmental information for Atectura Breezhaler (indacaterol, mometasone furoate) from Novartis (downloaded 2022-01-18).
Hazard
Persistence: Ready degradability: 0 % degradation in 28 days, not readily biodegradable (OECD301D). ... Indacaterol is not readily biodegradable. Therefore, the phrase “Indacaterol is potentially persistent” is chosen.
Bioaccumulation: Log P = -0.74 at 20.1°C (EC440/2008 A.8 8).
Toxicity: There are data for 3 trophic levels, fish "(Piecilia reticulata, guppy)
LC50 96 h (mortality) > 100.0 mg/L (OECD203)". Comment: Values reported as greater than are not according to the guidelines. The actual value may be lower.
Risk
PEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 0.000000972 which gives the risk insignificant.
Author: Health and Medical Care Administration, Region Stockholm