Ramipril

Detailed information

Fass environmental information

Fass environmental information for Ramipril/Hydrochlorothiazide Krka (downloaded 2021-06-29).

The environmental information for ramipril is produced by the company Sanofi AB for Ramipril Winthrop, Tazko, Tazko mite, Triatec^®, Triatec^® H.O.P., Triatec^® Start, Triatec^® comp, Triatec^® comp mite. All these drugs are withdrawn from the Swedish market.

Hazard

Persistence:"Ready biodegradability: Test results showed 20 to 50 % degradation in 28 days. (Protocol: OECD 301A; method of analysis DOC decrease). Ramipril failed to pass the ready degradation test according to OECD criteria, hence "Ramipril is potentially persistent."

Bioaccumulation: Log K_ow = 3.77 (Hansch Leo method). The substance has a low potential to bioaccumulation.

Toxicity: There are data for 3 trophic levels. All are equally sensitive > 100,000 microg/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 2017. PEC/PNEC = 0.000375 which gives the risk insignificant.

Report Goodpoint 2019

Comparative environmental risk assessment using angiotensin converting enzyme (ACE) inhibitors enalapril, ramipril, lisinopril and captopril from a Swedish perspective (Report Goodpoint 2019).

ACE inhibitors are sold in large quantities but all the compared substances (except ramipril) and active metabolites are very water soluble with very low potential to accumulate in aquatic biota to levels that are considered to pose a risk. For ramipril, there is a certain risk that the substance reaches the environment and bioconcentrates in biota sufficiently to cause a pharmacological effect. However, there is no bioconcentration data for the substances. Available toxicity tests indicate low toxicity to aquatic organisms, but they are acute tests and are not designed to address the specific effects of ACE inhibitors.

Although the environmental risk is highest for ramipril, the overall evidence for environmental risk is still low. No exchanges for environmental reasons are therefore recommended. More research on ramipril and its potential for bioconcentration and toxicity (chronic and mechanism-based) is desirable.