Olaparib

Detailed information

General information about assessment reports

Since 2006, an Environmental Risk Assessment (ERA) for the active pharmaceutical substance shall accompany an application for a marketing authorisation in EU for a medicinal product for human use. Parts of environmental data are available in the public assessment report (PAR/EPAR for centrally approved medicines). Environmental considerations are not included in the benefit-risk assessment for human medicines. If new data emerge after approval that necessitate an update of the environmental risk assessment, a variation application (“type IB C.I.z variation”) must be submitted to the regulatory authority.

Assessment report

"The potential environmental impact from use of the drug substance olaparib has already been evaluated at the time of the initial marketing authorisation application and as part of previous extensions of indication. An update to the ERA for Lynparza was submitted to support this extension of indication." Assessment report for Lynparza (olaparib), AstraZeneca, 27 June 2024, EMA/346655/2024.

Hazard

Persistence: DT_{50 total system} = 251–551 days.

Bioaccumulation: Log P_ow = 1.55 at pH 7.

Toxicity: There are data for 3 trophic levels, most sensitive fish and crustaceans NOEC 320 microg/L.

Risk

The risk, PEC/PNEC, calculated from data in the assessment report from a European perspective:

PECsurfacewater = 0.180 microg/L.

PNEC = Lowest NOEC, 320 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 32 microg/L

PEC/PNEC = 0.0056 which gives the risk insignificant.

Fass environmental information

Fass environmental information for Lynparza from AstraZeneca (retrieved on 2026-02-19).

Hazard

Persistence: Log P_ow = 1.55 at pH 7.

Bioaccumulation: Olaparib shows low aerobic biodegradation in the OECD 301F test, with less than 6 % degradation after 28 days, indicating that it is not readily biodegradable. Adsorption studies report a sludge Kd of 25 L/kg and substantial variation between sediment types: high‑organic‑matter sediment showed a Kd of 111 L/kg (KOC 1986 L/kg), while low‑organic‑matter sediment exhibited much higher KOC values. In the OECD 308 study, rapid dissipation from the water phase was observed, but degradation in the whole water–sediment system was slow, with DT₅₀ values of 250–260 days (530–550 days at 12 °C). Overall, the data indicate that olaparib degrades slowly in sediment and is therefore considered potentially persistent.

Toxicity: There are data for 3 trophic levels, most sensitive fish and crustaceans NOEC 320 microg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2023.

PEC = 0.0068 microg/L.

PNEC = Lowest NOEC, 320 microg/L/10 (Assessment Factor (AF) for 3 chronic studies) = 32 microg/L.

PEC/PNEC = 0.00021 which gives the risk insignificant.