Etravirine

Detailed information

Assessment report Intelence 2008

Assessment report for Intelence (etravirine), Doc.Ref.: EMEA/CHMP/43952/2008.

Hazard

Persistence: "Because etravirine is highly adsorbed on soil (K_oc 16.614 L/kg) and not readily biodegradable (DT₅₀ in soil 587 days), an additional sediment dweller test is currently being performed; the results from this study will be provided as post-approval commitment."

Bioaccumulation: No data.

Toxicity: "Zebra Fish in an early-life stage toxicity test was performed, and no toxic effects were noted."

Risk

PEC/PNEC soil = 0.000066 wich gives the risk insignificant.

Assessment report Intelence 2012

Assessment report for Intelence 15 November 2012, EMA/CHMP/546580/2012.

Hazard

Persistence: "The adsorption/desorption coefficients (K_oc) for activated sludge and soils indicates that ETR is immobile and will remain preferably in soil."

Bioaccumulation: Log P_ow = 3.4. BCF of 370.3 and 476.9 indicate that etravirine does not bioaccumulate in aquatic organisms.

Toxicity: No data.

Risk

"Concerning the aquatic fate and effect assessment (Phase II Tier A), the ratios PEC_surfacewater/PNEC_water and PEC_groundwater/PNEC_groundwater are below 1 and the ratio PEC_surfacewater/PNEC_{microorganisms} is below 0.1. Consequently, no further testing in the aquatic compartment is necessary and it can be concluded that etravirine and/or its metabolites are unlikely to represent a risk to the aquatic environment."

Assessment report Intelence 2020

Assessment report for Intelence, type II variation, 26 March 2020, EMA/175628/2020.

Hazard

Persistence: No data.

Bioaccumulation: Log P_ow = 3.4.

Toxicity: PNEC_groundwater is based on the NOEC result of the acute toxicity test with Daphnia magna. However, data for the NOEC is not provided.

Risk

PEC_surfacewater/PNEC_water = 0.2 μg/L/0.49 μg/L= 0.41.

Fass environmental information

Fass environmental information for Intelence from Janssen-Cilag (retrieved on 2025-06-30).

Hazard

Persistence: "Etravirine is slowly degraded to form four minor degradation products in an aerobic transformation test in aquatic sediment systems (OECD 308). Consequently, etravirine is not considered as readily biodegradable. The medicine is considered as potentially persistent."

Bioaccumulation: Log P_ow = 3.4. BCF_low dose = 370.3 and BCF_high dose = 476.9.

Toxicity: There are data for 3 trophic levels, most sensitive algae NOEC 4.9 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2022. PEC/PNEC = 0.0016205 which gives the risk insignificant.