Cinakalcet

Fass miljöinformation

Fass miljöinformation för Mimpara (cinakalcet) (hämtad 2019-01-24).

Fara

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 (VII): 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) (VIII, IX): 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 below (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 K_ow and log D_ow (see table 3 below). Log K_ow 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 D_ow at pH 7. Log Dow values equal to or greater than 4 indicate that the chemical may bioconcentrate or sorb significantly but as log D_ow is below 4 (3.53) this would rather indicate that cinacalcet has a low potential to bioaccumulate. Based on the log D_ow 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.

Risk

PEC/PNEC utgår från försäljningsdata i Sverige under år 2012. PEC/PNEC = 0,007 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 PEC surfacewater 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."