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Miljöinformation
MSD

DRAGEER 25 mg
Avregistreringsdatum: 1970-09-01 (Tillhandahålls ej)

ATC-kod: C03AB03
För information om det avregistrerade läkemedlet omfattas av Läkemedelsförsäkringen, kontakta Läkemedelsförsäkringen.
Läs mer om avregistrerade läkemedel

Miljöpåverkan (Läs mer om miljöpåverkan)

Hydroklortiazid

Miljörisk: Användning av hydroklortiazid har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Hydroklortiazid är potentiellt persistent.
Bioackumulering: Hydroklortiazid har låg potential att bioackumuleras.


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Detaljerad miljöinformation


Environmental Risk Classification


Predicted Environmental Concentration (PEC)

PEC is calculated according to the following formula:


PEC (μg/L) = (A*109*(100-R))/(365*P*V*D*100) = 1.5*10-6*A(100-R)


PEC = 0.41 μg/L


Where:

A = 2763 kg (total sold amount API in Sweden year 2015, data from IMS Health).

R = 0 % removal rate (worst case assumption)

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. I)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. I)


Predicted No Effect Concentration (PNEC)


Ecotoxicological studies


Crustacean, water flea (Daphnia magna):

Acute toxicity (OECD 202) (Ref. III)

EC50 48 h (mortality) > 500 mg/L


Chronic toxicity (OECD 211) (Ref. VI)

LC50 21 d (reproduction, survival, length) > 100 mg/L

NOEC 21 d (reproduction, survival, length) = 100 mg

F
ish, fathead minnow (Pimephales promelas):

Acute toxicity (OECD 203) (Ref.IV)

LC50 96 h (mortality) > 500 mg/L


Chronic toxicity (OECD 210) (Ref VI)

NOEC 30 d (hatchability, survival, length, weight) = 10 mg/L

Algae (Pseudokirchneriella subcapitata) (OECD 201) (Ref VI)

EC50 72 h (growth rate, yield) > 100 mg/L

NOEC 72 h (growth rate, yield) = 100 mg/L

Bacteria (Pseudomonas.putida) (Method by Bringham and Kuhn, 1980, modified by Slabbert, 1986) (Ref. II):

EC50 48 h (growth rate) > 32 mg/L


PNEC = 1 mg/L = 1000 µg/L (10 mg/L / 10) based on the chronic NOEC for the fish early life stage and an assessment factor (AF) of 10)


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.41/1000 = 4.1 x10-4, i.e. PEC/PNEC ≤ .1 which justifies the phrase "Use of hydrochlorothiazide has been considered to result in insignificant environmental risk."


Degradation


Abiotic degradation


Hydrolysis & Photolysis:


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 21oC 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. IV). 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


Partitioning coefficient:

Log Kow = -0.07 at pH 7 (OECD 107) (Ref. V)


Justification of chosen bioaccumulation phrase:

Since log Kow < 4 at pH 7, the substance has low potential for bioaccumulation


.

References

  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. ICI Brixham Laboratory, 1988. “Hydrochlorothiazide: Bacterial growth inhibition Determination of the toxicity to Pseudomonas putida”, 12 July 1988.

  3. ICI Brixham Laboratory, 1989. “Hydrochlorothiazide: Determination of the acute toxicity to Daphnia magna”, 13 June 1988.

  4. Merck Internal Memo: Venkataramani to Bacher, MK-0152 (Hydrochlorothiazide) Ecotoxicological Characterization, March 30, 1994.

  5. Pubchem, 2017. http://pubchem.ncbi.nlm.nih.gov/compound/3639#section=Solubility

    accessed 20 April, 2017.

  6. Astra Zeneca, 2012. Environmental Risk Assessment Data Hydrochlorothiazide.