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Baricitinib

Hazard 4 P 3 B 0 T 1 Risk Insignificant

Information

This summary information comes from assessment report for Olumiant (baricitinib).

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.

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