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Prilocaine

Information

This summary information on persistence, bioaccumulation and toxicity comes from the assessment report for Lidocaine/Prilocaine Plethora and Fass. The risk comes from Fass.

Persistence. It cannot be excluded that prilocaine is persistent, due to the lack of data.
Bioaccumulation. Prilocaine has low potential for bioaccumulation.
Toxicity. It cannot be excluded that prilocaine is toxic, due to the lack of data.
Risk. Risk of environmental impact of prilocaine cannot be excluded, due to the lack of environmental toxicity data.

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 Lidocaine/Prilocaine Plethora

Assessment report for Lidocaine/Prilocaine Plethora (lidocaine, prilocaine), Plethora Solutions Ltd., 19 September 2013, EMA/685541/2013.

Hazard

Persistence: No data.

Bioaccumulation: Log Kow = 2.11.

Toxicity: No data.

Risk

PECsurfacewater = 0.0017. "Lidocaine/Prilocaine PECsurfacewater value is below the action limit of 0.01 µg/L and is not a PBT substance as log Kow does not exceed 4.5. Therefore Lidocaine/Prilocaine is not expected to pose a risk to the environment."

Assessment report Senstend

Assessment report for Senstend (lidocaine, prilocaine), Plethora Pharma Solution Limited, 19 September 2019, EMA/625405/2019.

"Since this application is an informed consent application, the medicinal product subject to this application is intended to be administered at comparable dose levels and for indications that were already approved in the Union for Fortacin. Based on the assumption that Senstend cutaneous spray, solution is intended to substitute for identical products on the market and it is unlikely to result in any significant increase in combined sales volumes, the approval of the product does not result in an increase of the total quantity of the active ingredients released into the environment. This justification is considered acceptable and in accordance with the Guideline on the environmental risk assessment of medicinal products for human uses (EMEA/CHMP/SWP/4447/00)."

Fass environmental information

Fass environmental information for Denela (lidocaine, prilocaine) from Teva (downloaded 2022-02-09).

Hazard

Persistence: No data.

Bioaccumulation: Log Pow = 2.11.

Toxicity: No data.

Risk

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

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.

Author: Health and Medical Care Administration, Region Stockholm