Melatonin

Detailed information

Fass environmental information

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

Hazard

Persistence: No data.

Bioaccumulation: Log P_ow = 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 PEC_{surface 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 PEC_{surface 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 K_ow = 1.18 ± 0.12.

Toxicity: No data.

Risk

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