Baricitinib
Summary
Persistence. Baricitinib is potentially peristent according to expert (Researcher at the Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University 2020-05-06).
Bioaccumulation. Baricitinib has low potential for bioaccumulation.
Toxicity. Baricitinib has moderate chronic toxicity.
Risk. Expected use of baricitinib from a European perspective gives the risk insignificant.
This summary information comes from assessment report for Olumiant (baricitinib).
Detailed information
Assessment report
Assessment report for Olumiant 15 December 2016 EMA/13493/2017.
Hazard
Persistence:"DT50 water: 10.8/24.0 d. DT50 system 165/132 d. Compound shifts to sediment, 38–47% over the duration of the test" (OECD 308). Remarks. "Results obtained in two river systems; sediment risk assessment triggered." Baricitinib is potentially peristent according to expert (Researcher at the Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University 2020-05-06).
Bioaccumulation: log Kow 1.4 (pH 5), 1.4 (pH 7) and1.5 (pH 9).
Toxicity: There are data for 3 trophic levels, most sensitive fish (Pimephales promelas) NOEC 600 microg/L.
Risk
The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:
PECsurface water, default Fpen = 0.02 microg/L.
PNEC = Lowest NOEC, 600 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 60 microg/L
PEC/PNEC = 0.00033 gives the risk insignificant.
Fass environmental information
Environmental information for the substance is not available on fass.se (2020-05-26). It is voluntary for manufacturers to publish environmental impact information on fass.se.
Author: Health and Medical Care Administration, Region Stockholm