Bazedoxifene
Summary
This summary information comes from the assessment report from 2014.
Persistence. Bazedoxifene is not persistent.
Bioaccumulation. Bazedoxifene has low potential for bioaccumulation.
Toxicity. Bazedoxifene has very high chronic toxicity.
Risk. "The data provided by the Applicant do allow concluding that bazedoxifene is unlikely to present a risk to the environmental compartments surface water, groundwater and sediment as well as wastewater microorganisms. No final conclusion is possible on the potential risk of bazedoxifene to the terrestrial environment. [...] The Environmental Risk Assessment of bazedoxifene and estrone/17β-dihydroequilin cannot be concluded until the Applicant will provide the missing data and the revised ERA. It was agreed that this will be done post-authorisation by 31 March 2015." No such information has been found on the EMA's website (2021-06-11).
Detailed information
Fass environmental information
Environmental information is missing on fass.se for bazedoxifene (2021-06-11). It is voluntary for manufacturers to provide information on environmental impact on fass.se.
Assessment report
Assessment report for Duavive (bazedoxifene; estrogens conjugated), Pfizer, 23 October 2014, EMA/CHMP/383987/2014.
Hazard
Persistence OECD 308 normalized to 12°C:
Aerobic
DT50, water = 4.1 / 6.4 d (SFO=
DT50, sediment = no data
DT50, whole system = 4.9 / 13.7 d (SFO)
% shifting to sediment = >10%
Anaerobic
DT50, water = 9.4 / 19.2 d (SFO)
DT50, sediment = no data
DT50, whole system = 7.8 / 17.1 d (FOMC)
% shifting to sediment = >10%
Bioaccumulation: BCF = 98.
Toxicity: There are data for 3 trophic levels, most sensitive algae NOEC 7.8 microg/L.
Risk
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PECsurfacewater, default or refined (e.g. prevalence, literature) = 0.1 microg/L.
PNEC = Lowest NOEC, 7.8 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.78 microg/L
PEC/PNEC = 0,1282 which gives the risk low.
Other concerns
Endocrine disrupting properties.
Conclusion in the assessment report
The Environmental Risk Assessment of bazedoxifene and estrone/17β-dihydroequilin cannot be concluded until the Applicant will provide the missing data and the revised ERA. It was agreed that this will be done post-authorisation by 31 March 2015." No such information has been found on the EMA's website (2021-06-11).
Author: Health and Medical Care Administration, Region Stockholm