Miljöpåverkan
Zidovudin
Miljörisk:
Risk för miljöpåverkan av zidovudin kan inte uteslutas då det inte finns tillräckliga ekotoxikologiska data.
Nedbrytning:
Zidovudin är potentiellt persistent.
Bioackumulering:
Zidovudin har låg potential att bioackumuleras.
Läs mer
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 = 8.1 x 10-5 μg/L
Where:
A = 0.81 kg (total sold amount API in Sweden year 2020, data from IQVIA).
R = 0% removal rate (conservatively, it has been assumed there is no loss by adsorption to sludge particles, by volatilization, hydrolysis or biodegradation)
P = number of inhabitants in Sweden = 9 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Reference 1)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Reference 1)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Green Algae:
No data
Water flea (Daphnia magna):
Acute toxicity
EC50 48 h (immobility) > 1,000,000 μg/L (OECD 202) (Reference 6)
NOEC > 1,000,000 μg/L
Water flea (Daphnia magna):
Chronic toxicity
EC50 21 days (reproduction) > 100,000 μg/L (OECD 211) (Reference 7)
NOEC = 16,000 μg/L
Rainbow Trout:
Acute toxicity
No data
Other ecotoxicity data:
EC50 3 hours (Inhibition) =102,000 μg/L (OECD 209) (Reference 5)
PNEC cannot be calculated because data is not available for all three (algae, crustacean and fish) of the short-term toxicity endpoints.
Environmental risk classification (PEC/PNEC ratio)
Risk of environmental impact of zidovudine cannot be excluded, since there is not sufficient ecotoxicity data available.
Degradation
Biotic degradation
Ready degradability:
0.23% degradation in 28 days (OECD 301B) (Reference 3)
Inherent degradability:
0% degradation in 28 days (OECD 302B) (Reference 4)
50% primary (loss of parent) degradation in 3 days
Abiotic degradation
Hydrolysis:
Half-life, pH 7 > 1 year (OECD 111) (Reference 7)
Photolysis:
No data
Justification of chosen degradation phrase:
Zidovudine is not readily biodegradable nor inherently biodegradable. The phrase “Zidovudine is potentially persistent” is thus chosen.
Bioaccumulation
Partitioning coefficient:
Log Kow = 0.06 (TAD 3.02) (Reference 7)
Justification of chosen bioaccumulation phrase:
Since log Dow < 4, the substance has low potential for bioaccumulation.
Excretion (metabolism)
Zidovudine is primarily eliminated by hepatic conjugation to an inactive glucoronidated metabolite. The 5'-glucuronide of zidovudine is the major metabolite in both plasma and urine, accounting for approximately 50-80% of the administered dose eliminated by renal excretion. 3'-amino-3'-deoxythymidine (AMT) has been identified as a metabolite of zidovudine following intravenous dosing. Renal clearance of zidovudine greatly exceeds creatinine clearance, indicating that significant tubular secretion takes place. (Reference 2)
PBT/vPvB assessment
Zidovudine does not fulfil the criteria for PBT and/or vBvP.
All three properties, i.e. ‘P’, ‘B’ and ‘T’ are required in order to classify a compound as PBT (Reference 1). Zidovudine does not fulfil the criteria for PBT and/or vBvP based on a log Kow < 4.
Please, also see Safety data sheets onhttp://www.msds-gsk.com/ExtMSDSlist.asp.
References
-
ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.
-
Pharmacokinetic properties: Metabolism and Elimination. Summary of Product Characteristics Retrovir (Zidovudine) 100mg Capsules. ViiV Healthcare, May 2013.
-
Gorman M. Aerobic Biodegradaion in Water using C14 Zidovudine. Report No. 41035. ABC Laboratories Limited, April 1994.
-
Ziegenfuss S. Zidovudine (GR63367X): Aerobic Biodegradation in Activated Sludge. Report No. ERL-2001-024. GlaxoSmithKline Environmental Laboratory, February 2002.
-
Koper CM. Acute Toxicity of GR63367X (Zidovudine) to Activated Sludge Microorganisms. PEET-2001-066. GlaxoSmithKline Environmental Laboratory, February 2002.
-
Ziegenfuss MC. Toxicity of GR63367X (Zidovudine) to Daphnia magna. PEET-2002-001. GlaxoSmithKline Environmental Laboratory, January 2002.
-
Material Safety Data Sheet for Retrovir (Zidovudine) Tablets. SDS number 127089. ViiV Healthcare plc, April 2011.