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Melatonin

Information

This summary information comes from Fass and data on bioaccumulation also from the assessment report for Slenyto (melatonin).

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

Detailed information

Fass environmental information

Fass environmental information for Circadin from Takeda Pharma (melatonin) (downloaded 2021-06-11).

Hazard

Persistence: No data.

Bioaccumulation: Log Pow = 1.65.

Toxicity: No data.

Risk

"Risk of environmental impact of melatonin cannot be excluded, since there is not sufficient ecotoxicity data available."

Assessment report for Circadin (melatonin) EMEA/H/C/695

"The initial environmental risk assessment included only a calculation of PECsurface water which was
wrong (0.00002 µg/l instead of 0.00002 mg/l for an intended maximum daily dose of 4 mg). The correct value is above the trigger value of 0.01 μg/l and therefore phase II studies are in principle needed. The applicant was requested to discuss the need for such studies. The re-calculated the PECsurface water on the basis of the new posology (2 mg/day) and the administration schedule proposed (3 weeks followed by 2 months interval, resulting in 15 weeks of exposure), resulted in a value below the trigger limit. Therefore further phase II studies were not requested by the CHMP considering that Circadin, at the recommended posology, did not present any potential risk to the environment."

Assessment report for Slenyto (melatonin) 26 July 2018, EMA/556280/2018

Hazard

Persistence: No data.

Bioaccumulation according to OECD 107: log Kow = 1.18 ± 0.12.

Toxicity: No data.

Risk

"PECsurfacewater , default or refined (e.g. prevalence, literature) = 0,0033 mikrog/L. > 0.01 threshold (N)."

Author: Health and Medical Care Administration, Region Stockholm