Hydrochlorothiazide

Detailed information

Comment on Fass environmental information

Hydrochlorothiazide has different classifications on fass.se. According to Lif (the trade association for the research-based pharmaceutical industry in Sweden) the various pharmaceutical companies compile environmental information for their active substances based on internal studies and published data. Based on data, which may thus differ between different pharmaceutical companies, the companies assess the environmental risk with guidance from “Environmental classification of pharmaceuticals at www.fass.se – Guidance for pharmaceutical companies 2012”. The Swedish Environmental Institute (IVL) reviews the assessment but does not have the task of coordinating/harmonizing environmental information from different pharmaceutical companies for the same active substance.

Fass environmental information from Novartis

Fass environmental information for hydrochlorthiazide from Diovan Comp (hydrochlorthiazide, valsartan) from Novartis (downloaded 2012-04-20).

Hazard

Persistence: "DT50 (total system) = 34.7 – 37.3 days (OECD 308). ... According to the pass criteria for OECD308 studies, hydrochlorothiazide can be classified as ‘Hydrochlorothiazide is slowly degraded in the environment' (DT₅₀ for total system < 120days)."

Bioaccumulation: Log D_ow = 0.09 at pH 7 (OECD107).

Chronisk toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas, fathead minnow) NOEC 30 days "(hatchability, survival, length and weight)" = 10,0 mg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2019. PEC/PNEC = 0.00042 which gives the risk insignificant.

Fass environmental information from AstraZeneca

Fass environmental information for CoAprovel (hydrochlorthiazide, irbesartan) from Sanofi AB (downloaded 2022-04-20). The environmental information for hydrochlorothiazide is provided by AstraZeneca for Zestoretic. Zestoretic is no longer approved.

Hazard

Persistence: "DT₅₀ (total system) = 34.7 days (OECD 308). ... The evidence from studies above (not readily biodegradable, total system DT₅₀ ≤ 120d) suggests that hydrochlorothiazide is slowly degraded. Therefore, the phrase “Hydrochlorothiazide is slowly degraded in the environment” has been assigned."

Bioaccumulation: Log P = 0.09 vid pH 7 (OECD107).

Toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas, fathead minnow) NOEC = 10,0 mg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2017. PEC/PNEC = 0.00041 which gives the risk insignificant.

Fass environmental information from MSD

Fass environmental information for Cosaar Comp (hydroklorthiazide, losartan) from Organon Sweden (downloaded 2022-04-20). The environmental information for hydrochlorothiazide is provided by MSD for Dichlotride, Dichlotride comp, Dichlotride-k, Fortzaar mite, Hydromet, Hydromet-k, Moduretic, Moduretic mite, Synerpril. All these medicinal products äre no longer approved.

Hazard

Persistence: "In laboratory studies performed to determine aqueous stability for aquatic toxicity tests, hydrolysis and/or photolysis effects were observed. A solution of 26 mg/L hydrochlorothiazide was prepared in Mullin's Spring Water (pH = 8.2) and incubated at 21 C under lighted conditions. The concentration of this solution was measured by HPLC at time 0 and 96 hours. A 53.8% recovery was noted, indicating that degradation of the compound was occurring (Ref. V). Hydrochlorothiazide has been found to be degradable in the environment, however no data is available on metabolites. Therefore the phrase “Hydrochlorothiazde is potentially persistent” was chosen."

Bioaccumulation: Log K_ow = -0.07 at pH 7 (OECD 107). 

Toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Pimephales promelas, fathead minnow) NOEC 30 days "(hatchability, survival, length and weight)" = 10,0 mg/L.

Risk

PEC/PNEC is based on sales data in Sweden in year 2018. PEC/PNEC = 0.0004 which gives the risk insignificant.

Fass environmental information from Pfizer

Fass environmental information for Accupro Comp (hydroklorthiazide, quinapril) from Pfizer (downloaded 2022-04-20).

Hazard

Persistence: No data.

Bioaccumulation: No data.

Toxicity: No data.

Risk

Risk of environmental impact of hydroklorthiazide cannot be excluded, due to the lack of environmental toxicity data. Manufacturer has on fass.se stated that data about the environmental impact is missing for the substance so that the environmental risk cannot be calculated. It is voluntary for manufacturers to provide information on the environmental impact on fass.se.

Pharmaceuticals residues in the aquatic environment in Region Stockholm

Hydrochlorothiazide has previously been included in screening programs and measured in the aquatic environment in Region Stockholm.