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Persistens. Cinakalcet är potentiellt persistent.

Bioackumulering. Cinakalcet har låg potential att bioackumuleras.

Toxicitet. Cinakalcet har hög kronisk toxicitet.

Risk. Användningen av Cinakalcet (försäljningsdata Sverige 2021) har bedömts medföra försumbar risk för miljöpåverkan.


Denna sammanfattande information kommer från Fass.se.

Detaljerad information

Fass miljöinformation

Fass miljöinformation för Mimpara (cinakalcet) (hämtad 2024-03-06).


Persistens: "Instrumental Respirometric Method to Determine Biodegradability /Inhibition/Toxicity (VI): Under the conditions of the study, cinacalcet did not appear to biodegrade based on respirometric measurements.

Sealed Vessel C02 Production Test ...: The test substance is not readily biodegradable under the study criteria. Cinacalcet did not pass the criteria of greater than 60% of the theoretical carbon dioxide production that would indicate a readily biodegradable compound within the 10-day test duration.

Aerobic and Anaerobic Degradation Transformation in Aquatic Systems (OECD 308) ...: Under the conditions of the test, recovery from the sediment was not achievable to the requirements of the OECD Method (70% recovery).

Based on these data and the physical-chemical properties described in Table 3 (se Fass-texten red. anm.) the following ummary phrase for degradation has been chosen: “Cinacalcet är potentiellt persistent.”"

Bioackumulation: "No Bioconcentration Factor (BCF) study was performed. In the absence of a measured BCF value, the bioaccumulation potential may be indicated from log Kow and log Dow (see table 3 below). Log Kow is 4.79 which indicates that the substance may bioaccumulate to a high degree. For complex ionizable molecules, such as cinacalcet, it may be more relevant to use log Dow at pH 7. Log Dow values equal to or greater than 4 indicate that the chemical may bioconcentrate or sorb significantly but as log Dow is below 4 (3.53) this would rather indicate that cinacalcet has a low potential to bioaccumulate. Based on the log Dow value the following phrase has been chosen: ”Cinacalcet har låg potential att bioackumuleras.”"

Toxicitet: Det finns data för 3 trofinivåer, känsligaste kräftdjur (Daphnia Magna) NOEC 25 mikrog/L.


PEC/PNEC utgår från försäljningsdata i Sverige under år 2021. PEC/PNEC = 0,011 vilket ger risken försumbar.

Assessment report

Assessment report för Mimpara (cinakalcet) 22 juni 2017 EMA/449274/2017

"In accordance with the ERA Q&A guidance (EMA/CHMP/SWP/44609/2010), if a product can be prescribed for the treatment of more than one indication, the PECsurfacewater values for all the sought indications should be calculated. The correct calculation is as follows: 0.022 + 0.605 + 0.00605 + 0.0005319 = 0.633 μg/L. This is well above the trigger value of 0.01 μg/L and thus a Phase II, Tier A environmental fate and effects analysis is requested. Since this was already provided in the original MAA for Mimpara, no further action is considered necessary."

Författad vid avdelningen Kunskapsutveckling, Region Stockholm