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 comes from Fass.se. For the risk, see the report Goodpoint 2019.
Fass environmental information for Renitec (enalapril) (downloaded 2019-12-04).
Persistence: "As no degradation studies are available, the phrase, “The potential for persistence of enalapril cannot be excluded”, is thus chosen."
Bioaccumulation: "Log Kow = 0.59 (method not provided)."
Acute toxicity: There is data for 2 trophic levels, lowest for crustacean (Daphnia magna) EC50 48 h (mortality) 346 mg/L (OECD 202).
Sales data in Sweden are available for 2015. "As data are not available for three trophic levels, an environmental risk classification is not possible."
Enalapril has previously been found in purified wastewater in Region Stockholm 2007. Enalapril has not been analyzed in recent years.
The reduction rate for enalapril in wastewater treatment plants in Region Stockholm is between 96 och 99 %.
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