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Cinacalcet

Hazard 5 P 3 B 0 T 2 Risk Insignificant

Information

The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B, T and risk are from Fass.

Fass environmental information

Fass environmental information for Mimpara (cinacalcet) (downloaded 2019-01-24).

Hazard

Persistence: "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.”"

Bioaccumulation: "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.”"

Toxicity: There are data for 3 trophic levels, most sensitive crustacean (Daphnia Magna) NOEC 25 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2012. PEC/PNEC = 0.007 which gives the risk insignificant.

Assessment report

Assessment report for Mimpara (cinacalcet) 22 June 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."

Author: Health and Medical Care Administration, Region Stockholm