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Persistence. Guanfacine is not persistent.

Bioaccumulation. Guanfacine has low potential for bioaccumulation.

Toxicity. Guanfacine has very high chronic toxicity.

Risk. The use of guanfacine from a European perspective (2015) has been considered to result in a low risk of environmental impact.


This summary information comes from assessment report for Intuniv (guanfacine).

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

Assessment report for Intuniv (guanfacine), 23 July 2015, EMA/CHMP/534329/2015.


Persistence: OECD 308:
DT50 water = 4.1/5.1 d (l/l)
DT50 sediment = 58/118 d (l/l)
DT50 system = 6.9/7.9 d (l/l)
Sediment shifting >10% at or after 14 days. l = lake, DT50 values at 20°C; Significant shifting to sediment observed.

Bioaccumulation: log Kow = 1.8.

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia magna) NOEC 0.78 microg/L.


The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PECsurface water, default Fpen = 0.035 microg/L.

PNEC = Lowest NOEC, 0.78 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 0.078 microg/L

PEC/PNEC = 0.45 which gives the risk low.

Author: Health and Medical Care Administration, Region Stockholm