Hazard 3 P 3 B 0 T 0 Risk Low
The T-value in the score for hazard refers to acute toxicity. Underlying data for P, B and T are from Fass. For the risk, see the report Goodpoint 2019.
Fass environmental information for Triatec (ramipril) from Sanofi AB (downloaded 2019-12-04).
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 Kow = 3.77 (Hansch Leo method).
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.
PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.000375 which gives the risk insignificant.
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.
Author: Health and Medical Care Administration, Region Stockholm