Hazard 5 P 3 B 0 T 2 Risk See below
Data on P, B and T are from Mysimba (naltrexone/bupropion) assessment report December 18, 2014, EMA / 805547/2015 but also from Fass environmental information for Voxra (bupropion) (obtained 2018-05-29) regarding the assessment of P. T refers to chronic toxicity.
Concentrations of bupropion in the environment have been well below the lowest effect concentrations. Bupropion has been found in wild fish, though quite far below therapeutic concentrations. Mechanism based efficacy data is lackning.
Bupropion has been detected in treated wastewater and surface water in Stockholm County in the last five years (2012-2016).
Is recommended in The Wise List. Environmental classification of pharmaceuticals is taken into consideration, sometimes with other environmental aspects, when selecting pharmaceuticals for the Wise List. When comparable pharmaceuticals are equivalent to medical effects, safety and pharmaceutical efficacy, environmental impact and price are considered.
Assessment report for Mysimba (naltrexon/bupropion) 18 december 2014, EMA/805547/2015.
Persistence: "OECD 301: 1.21 % in 14 days. Not ready biodegradable. OECD 301B: 0.2–1.0 % CO2. Not ready biodegradable. OECD 302: 90 % in 14 days. Inherent biodegradable. [---] CHMP recommends the following points for further investigation: The Applicant is requested to perform all the planned studies for the environmental risk assessment for bupropion (e.g. OECD 106, 210 and 211) and naltrexone (OECD 106, 201, 209, 210, 211 and 301) as well as OECD 308 for both compounds, should the results from the respective OECD 301 studies deem this necessary." According to contact person at the Swedish Medical Products Agency, no new data has been received (email 2018-09-04).
Bioaccumulation: log Kow pH 5: -0.207, pH 7: 1.83, pH 9: 3.18. Conclusion: not B.
Toxicity: There are data for 3 trophic levels, most sensitive algae (Pseudokirchneriella sucapitata) NOEC = 11.1 microg/L.
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PEC = 0.068 microg/L
PNEC = Lowest NOEC, 11.1 microg/L/50 (assessment factor (AF) for two chronic studiesr) = 0,222 mikrog/L
PEC/PNEC = 0.306 gives the risk low
Fass environmental information for Voxra (bupropion) (obtained 2018-05-29).
Persistence: "This substance is not inherently biodegradable." Bupropion is indicated as potentially persistent.
Bioaccumulation: Log Dow = 1.54 vid pH 7.4 (TAD 3.02)
Toxicity: There are data for 3 trophic levels, most sensitive NOEC for fish 100 microg/L.
The risk classification insignificant, according to Fass.se, (PEC/PNEC = 0.0186) is based on total sold amount (kg) of the substance in Sweden during the year 2014 and the toxicity of the substance, i.e. consideration has not been given to measured levels in the environment.
Author: Health and Medical Care Administration, Region Stockholm