Roflumilast
Summary
The data on hazard and risk are based on previous environmental information on fass.se. Environmental information is missing (2022-01-26). It is voluntary for manufacturers to provide information about environmental impact on fass.se.
Persistence. Roflumilast is potentially persistent.
Bioaccumulation. Roflumilast has low potential for bioaccumulation.
Toxicity. Roflumilast has very high acute toxicity.
Risk. The use of roflumilast (sales data Sweden 2014) 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 Daxas 2010
Assessment report for Daxas (roflumilast), Nycomed GmbH, 22 April 2010, EMA/464905/2010.
"An environment risk assessment for roflumilast was performed. Roflumilast PECsurfacewater value is 2.5 x 10-3 μg/L below the action limit of 0.01 μg/L and is not a PBT substance as log Kow does not exceed 4.5. Considering the above data, roflumilast should be used according to the precautions stated in the SPC in order to minimize any potential risks to the environment."
Utredningsrapport Daxas 2018
Assessment report for Daxas (roflumilast), AstraZeneca AB, 22 February 2018,
EMA/154975/2018.
"The Applicant has submitted no additional nonclinical data supporting a lower starting dose. No modification of the benefit risk profile of Roflumilast is expected. With regards to the Environmental Risk Assessment, no additional studies were submitted. The Applicant estimates that no increase in the environmental exposure is anticipated, given that the proposed starting dose is lower than the previously approved."
Fass environmental information
Fass environmental information for Daxas (roflumilast) from Takeda Pharma (downloaded 2016-04-05).
Hazard
Persistence: "OECD 301: The biological degradability of the test item is stated as the percentage of the BOD/ThOD ratio under inclusion of the sample concentration. Roflumilast reached a mean degradation of 11,6% after 21 days. Test items giving a measured BOD greater than 60% of the ThOD within 28 days are considered to be readily biodegradable. The test item roflumilast was not degraded to about 60% in 28 days and roflumilast is therefore considered to not readily degraded in the environment. Roflumilast is potentially persistent."
Bioaccumulation: Log Kow (pH 7.4) = 3.99, method unknown ... Since log Kow < 4, the substance has low potential for bioaccumulation."
Toxicity: There are data for 3 trophic levels, most sensitive algae NOEC (Desmodesmus subspicatus) 43 microg/L.
Risk
PEC/PNEC is based on sales data in Sweden in year 2014. PEC/PNEC = 97,6 x10-3 which gives the risk insignificant.
Author: Health and Medical Care Administration, Region Stockholm