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 (Lisinopril) from AstraZeneca (downloaded 2019-12-04).
Persistence: "0% biodegradation after 28 days (OECD 301C). "Based on this information (considering that no other data is available) the substance has been assigned the risk phrase: "Lisinopril dihydrate is potentially persistent."
Bioaccumulation: "Since Log P < 4 the phrase "Lisinopril dihydrate has low potential for bioaccumulation” is assigned."
Toxicity: There are data for 3 trophic levels, most sensitive algae (Pseudokirchneriella subcapitata) and crustaceans (Daphnia magna) 120,000 microg/L.
PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.000052 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