Atropine
Summary
Persistence. It cannot be excluded that atropine is persistent, due to the lack of data.
Bioaccumulation. Atropine has low potential for bioaccumulation.
Toxicity. It cannot be excluded that atropine is toxic, due to the lack of data.
Risk. Risk of environmental impact of atropine cannot be excluded, due to the lack of environmental toxicity data.
This summary information comes from Fass.
Detailed information
Fass environmental information for Atropin Aguettant
Fass environmental information for Atropin Aguettant (atropine) from Laboratoire Aguettant (downloaded 2024-07-03).
Hazard
Persistence: No data.
Bioaccumulation: Log Kow = -3.2 at 7 (guideline OECD 107).
Toxicity: No data.
Risk
PECsurfacewater = 0.015 µg/L
Since this value is higher than 0.01 µg/L a Fpen refined has been used.
Fpen refined = 0.0000685
PECsurfacewater = 0.000103 mikrog/L
Risk of environmental impact of atropine cannot be excluded, due to the lack of environmental toxicity data.
Comment. According to environmental information for Atropin Aguettant, atropine has only undergone a phase I study according to regulatory requirements for environmental risk assessments (European Medicines Agency, EMA: Committee for Medicinal Products for Human Use (CHMP). Guideline on the environmental risk assessment of medicinal products for human use, EMEA/CHMP/SWP/4447/00 corr 2.) A phase I study includes data on bioaccumulation and calculates the concentration of atropine in the environment (PECSurface water). If specified limit values are not exceeded, the company does not need to conduct a phase II study that includes data on toxicity and persistence and calculation of risk based on PEC/PNEC.
Fass environmental information for Atropin Abboxia
Fass environmental information for Atropin Abboxia (atropine) from Abboxia (downloaded 2024-07-03).
Hazard
Persistence: No data.
Bioaccumulation: Log D = -0,61 at pH 7.4.
Toxicity: No data.
Risk
Risk of environmental impact of atropine cannot be excluded, due to the lack of environmental toxicity data.
References
Author: Health and Medical Care Administration, Region Stockholm