Hexaminlevulinate
Summary
Persistence. It cannot be excluded that hexaminolevulinate is persistent, as data are lacking.
Bioaccumulation. Hexaminolevulinate has low potential for bioaccumulation.
Toxicity. It cannot be excluded that hexaminolevulinate is toxic, as data are lacking.
Risk. The use of hexaminolevulinate (sales data Sweden 2021) has been considered to result in insignificant environmental risk. See comment under Detailed Information.
This summary information comes from fass.se.
Detailed information
Fass environmental information
Fass environmental information for Hexvix (hexaminolevulinate) from Photocure (retrieved on 2025-07-07).
Hazard
Persistence: No data.
Bioaccumulation: Bioaccumulation Log Dow was experimentally determined at four pH levels (4.7–8.1), ranging from 1.09 to 1.21, consistent with the pKa of 8.16 for hexaminolevulinate HCl depended on the pH. The variation of Log Dow values are as expected since the % of deprotonated amino group increase with increased pH increasing the lipophilicity of the molecule.
Due to degradation, the mass balance was low. The Log Dow at pH 8.1 was corrected for recovery, resulting in a value of 1.29. An extrapolated Log Pow at pH 9.16 was estimated at 1.68.
Since all values are below 4.0, no further assessment is required. The substance is considered to have low potential for bioaccumulation.
Toxicity: No data.
Risk
PEC = 0.000273 µg/L. With reference to Guideline EMA/CHMP/SWP/4447/00, medicinal products with PEC values below 0.01 µg/L are assumed unlikely to pose a risk to the environment when used as prescribed in patients. Therefore, no further environmental risk assessment has been presented for hexaminolevulinate hydrochloride. Comment: Risk is normally assessed based on the PEC/PNEC ratio.
References
Author: Health and Medical Care Administration, Region Stockholm