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Ulipristal

Summary

The data on hazard and risk are based on previous environmental information on fass.se. Environmental information is missing (2022-04-11). It is voluntary for manufacturers to provide information about environmental impact on fass.se.

Persistence. It cannot be excluded that ulipristal is persistent, due to the lack of data.
Bioaccumulation. Ulipristal has the potential to be stored in aquatic organisms.
Toxicity. It cannot be excluded that ulipristal is toxic, due to the lack of data.
Risk. Risk of environmental impact of ulipristal cannot be excluded, due to the lack of environmental toxicity data.

This summary information comes from Fass 2011-04-29. See further the report from Goodpoint under "Detailed information".

Detailed information

Fass environmental information

Fass environmental information forellaOne (ulipristal) from Nycomed (downloaded 2011-04-29).

Hazard

Persistence: No data.

Bioaccumulation: Log Kow=4.2.

Toxicity: No data.

Risk

Risk of environmental impact of ulipristal cannot be excluded, due to the lack of environmental toxicity data.

Report from Goodpoint 2017

Measurements in the environment and effect data on aquatic organisms are missing, even internationally. Ulipristal is not considered to be readily degradable (theoretical assessment). One of the urine metabolites of ulipristal is active. Estimated fat solubility (log Pow) for ulipristal is high enough to cause significant bioconcentration in fish. Note that calculation of ulipristal acetate's ability to bioaccumulate is irrelevant, as ulipristal acetate is the more water-soluble prodrug that will not reach the environment.

Ulipristal does not bind to the Sex Hormone Binding Globulin (SHBG) as opposed to levonogestrel. Binding to SHBG is suspected to be an important cause of the exceptionally high bioconcentration ability (and thus potency) observed in fish for levonorgestrel. Therefore it is possible that ulipristal accumulates less in fish compared to levonorgestrel despite higher log Pow.

Comparison with levonorgestrel

The replacement of levonorgestrel with ulipristal as an emergency contraception pharmaceutical may only cause small effects of the levonogrestrel concentration in the environment, as the replacement includes only part of the use of levonorgestrel. At the same time, exchange may result in a corresponding increase in the level of ulipristal in the environment.

It is unclear whether ulipristal is less potent for fish than levonorgestrel is. If ulipristal accumulates in fish to levels approaching therapeutic levels, it is likely that the reproduction may be disturbed, based on the effect mechanism. Due to insufficient data about both levels in the environment and effects of ulipristal, risk assessments are very uncertain. Therefore, from an environmental point of view, a levonorgestrel replacement of ulipristal is not recommended, but it may be relevant if relevant data on environmental spreading, bioconcentration and effects are obtained for ulipristal.

Author: Health and Medical Care Administration, Region Stockholm