Bedaquiline

Detailed information

Assessment report for Sirturo 2021

Assessment report for Sirturo (bedaquiline), 28 January 2021, EMA/CHMP/598014/2020, type II variation.

Hazard

Persistence: Freshwater DT₅₀: 2.7 days, Sediment DT₅₀: 257 days.

Bioaccumulation: BCF 1433 and 2049.

Toxicity: There are data for 3 trophic levels: algae: 0.77µg/L, Daphnia: 4.7 µg/L, Fish: 4.1 µg/L.

Risk

"Using this PEC_surfacewater to calculate risk quotients (ratio PEC_surfacewater/PNEC_water is below 1; 0.00084 μg/L / 0.077 μg/L), no risk is identified for any of the compartments, but since the substance is a PBT, the following wording has been included in the Package Leaflet: This medicine may pose a risk to the environment. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment."

Assessment report for Sirturo 2013

Assessment report for Sirturo, 19 December 2013, EMA/CHMP/329898/2013.

The report contains more detailed data on environmental risk and the following: "As the substance meets the PBT criteria as specified in the REACH regulation no safe level can be established and therefore no standard risk assessment based on comparison of PEC/PNEC is applicable. Adequate wording was included in the SIRTURO SmPC."

Fass environmental information

Fass environmental information for Sirturo from Janssen (downloaded 2024-07-04).

Hazard

Persistence: "Water DT₅₀: 2.7 days, Total system DT₅₀: 257 days. ... Conclusion for degradation: Bedaquiline is potentially persistent."

Bioaccumulation:
BCF_low dose = 1433
BCF_high dose = 2049
Conclusion for bioaccumulation: Bedaquiline has high potential for bioaccumulation.

Toxicity: There are data for 3 trophic levels, most sensitive algae NOEC 0.77 microg/L. Written as ≥ 0.77 micrograms/L.
Comment: Values reported as greater than are not according to the guidelines. The actual value may be lower.

Risk

PEC/PNEC is based on sales data in Sweden in year 2022. PEC/PNEC = 0.00137485528 which gives the risk insignificant. "The calculated PEC/PNEC ratio is ≤ 0.1. Hence, risk assessment procedures would indicate that bedaquiline would have insignificant long-term risk to the environment. However, the half-life in the environment is > 120 days, the BCF is > 2000 and the chronic toxicity is < 0.01 mg/L (NOEC). Bedaquiline should therefore be regarded as a PBT substance, according to ECHA Guidance criteria, and as such the current PEC/PNEC ratio may underestimate the potential for longterm risk to aquatic organisms."