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Promethazine

Information

This summary information comes from the report by Goodpoint 2017 and Fass (bioaccumulation).

Persistence. It cannot be excluded that promethazine is persistent, due to the lack of data.
Bioaccumulation. Promethazine has high potential for bioaccumulation.
Toxicity. Studies on the toxicity have only been carried out on one specie (water flea shows effects on reproduction at 180 microg/L), that makes a calculation of the environmental risk becomes uncertain.
Risk. Promethazine is not as well investigated for effects, but the substance has a fat solubility that indicates high potential for bioaccumulation. However, despite investigations in many countries, including Sweden, promethazine has not been detected in wastewater. The environmental risk of promethazine is therefore considered low.

Detailed information

Fass environmental information

Fass environmental information for Lergigan (promethazine) from Meda (downloaded 2021-07-02).

Hazard

Persistence: It cannot be excluded that promethazine is persistent, due to the lack of data.

Bioaccumulation: Log P of 4.81.

Toxicity: It cannot be excluded that promethazine is toxic, due to the lack of data.

Risk

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

Comment

The manufacturer has on fass.se stated that data about the environmental impact is missing for the substance so that the environmental risk cannot be calculated. It is voluntary for manufacturers to provide information on the environmental impact on fass.se.

Report from Goodpoint 2017

From the report "Comparative environmental risk assessments of possible substitutes for substances on Region Stockholm's list of environmentally harmful pharmaceutical substances 2017–2021".

Hazard

Persistence: Measurements of promethazine have been carried out in wastewater in several European countries including Sweden, but the substance has not been detected. Degradation data for promethazine is missing.

Bioaccumulation: Several independent sources report an estimated fat solubility (log Pow) between 4.29 and 4.8, indicating that the substance has a high potential for bioaccumulation.

Toxicity: Studies on the toxicity have only been carried out on one specie (water flea shows effects on reproduction at 180 microg/L), that makes a calculation of the environmental risk becomes uncertain.

Risk

Promethazine is not as well investigated for effects, but the substance has a fat solubility that indicates high potential for bioaccumulation. However, despite investigations in many countries, including Sweden, promethazine has not been detected in wastewater. The environmental risk of promethazine is therefore considered low.

In comparison to diazepam and oxazepam from a Swedish perspective

The risk of oxazepam has been assessed as "higher" based on measured concentrations in Swedish surface waters and in Swedish wild fish, and that these concentrations are very close to those that affect the behaviour of fish. Diazepam is metabolized to some extent into oxazepam and may therefore contribute to this risk, to what extent is unclear. [...] An exchange of oxazepam or diazepam for promethazine is therefore recommended from an environmental perspective.

Region Stockholm's list of environmentally harmful pharmaceutical substances

Diazepam and oxazepam are included in the Region Stockholm's list of pharmaceuticals with risk for negative environmental impact according to the environmental program 2017–2021. This is based on measured concentrations of oxazepam in Swedish surface water and in Swedish wild fish, and that these concentrations are very close to those affecting fish behavior. Diazepam is to some extent metabolised from oxazepam and may therefore contribute to this risk.

Author: Health and Medical Care Administration, Region Stockholm