Ropinirole

Detailed information

Fass environmental information

Fass environmental information for Adartrel (ropinirol) from GlaxoSmithKline AB (retrieved on 2026-04-22).

Excretion (metabolism)

Ropinirole is primarily metabolised by CYP1A2, and its metabolites are mainly excreted in the urine. The major metabolite is at least 100 times less potent than ropinirole in animal models. Ropinirole is eliminated with an average half-life of about 6 hours, and systemic exposure increases proportionally across the therapeutic dose range. No change in oral clearance is seen after single or repeated dosing, and wide inter-individual variability in pharmacokinetics has been observed.

Environmental information highlights ropinirole.

Hazard

Persistence: Ropinirole shows no ready degradability and less than 10% degradation after 28 days in inherent testing. Abiotic degradation is slow, with a hydrolysis half‑life of 163 days at 25 °C and pH 7.4, and photolysis proceeds very slowly with half‑lives ranging from 433 to 13 700 days. Overall, ropinirole is neither readily nor inherently degradable in microbial tests. It can be degraded by green algae in surface water, with a measured half‑life of 8.2 days, although degradation in wastewater treatment is not expected. The degradation products have not been identified and their ecotoxicity is unknown. Therefore, the phrase ropinirole is potentially persistent is applied.

Bioaccumulation: Log D_ow = 0.07 at pH 6.9 (TAD 3.02).

Toxicity: There are data for 3 trophic levels, most sensitive water flea (Ceriodaphnia dubia) NOEC 3200 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2022.

PEC = 5.10 x 10^-4 microg/L.

PNEC = Lowest NOEC, 3200 microg/L/50 (Assessment Factor (AF) for 2 chronic studies) = 64 microg/L.

PEC/PNEC = 7.97 x 10^-6 which gives the risk insignificant.