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MiljöinformationReceptstatusFörmånsstatus
GlaxoSmithKline

Pulver till injektions-/infusionsvätska, lösning 1,5 g
(Vitt till gräddvitt pulver)

Antibakteriellt medel för systemiskt bruk, andra generationens cefalosporiner

Aktiv substans:
ATC-kod: J01DC02
Läkemedel från GlaxoSmithKline omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöpåverkan (Läs mer om miljöpåverkan)

Cefuroxim

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


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Detaljerad miljöinformation


Detailed background information


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 = 0.023 μg/L


Where:

A = 153.16 kg (total sold amount API in Sweden year 2014, data from IMS Health).


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 (Selenastrum caprocornutum):

IC50 72h (inhibition of growth rate) > 76,000 μg/L (OECD 201) (Reference 3)

NOEC = 76,000 μg/L


Water flea (Daphnia magna):

Acute toxicity

EC50 48 h (immobility) > 831,000 μg/L (OECD 202) (Reference 3)

NOEC = 831,000 μg/L


Rainbow Trout (Oncorhyncus mykiss):

Acute toxicity

LC50 96 h (lethality) > 100,000 μg/L (OECD 203) (Reference 3)

NOEC = 100,000 μg/L


Other ecotoxicity data:


Microorganisms in activated sludge

EC50 3 hours (Inhibition) > 688,000 μg/L (OECD 209) (Reference 3)

NOEC = 688,000 μg/L


PNEC = 76,000/1,000 = 76 μg/L


PNEC (μg/L) = lowest EC50/1000, where 1000 is the assessment factor applied for three short-term EC50s. All EC50s are greater than values so NOEC for green algae (= 76,000 µg/L) has been used for this calculation since it is the most sensitive of the three tested species


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.023/76 = 3.03 x 10-4, i.e. PEC/PNEC ≤ 1 which justifies the phrase “Use of cefuroxime has been considered to result in insignificant environmental risk.”


Degradation


Biotic degradation

Ready degradability:

28% degradation in 28 days (OECD 301B) (Reference 3)

42% degradation in 64 days


Inherent degradability:

74% primary (loss of parent) degradation in 28 days (OECD 302B) (Reference 3)


Abiotic degradation


Hydrolysis:

Half-life, pH 7 = 30 hrs, (OECD 111) (Reference 3)

Half-life, pH 5 = 299 hrs.

Half-life, pH 9 = 1 hrs.


Photolysis:

No data


Justification of chosen degradation phrase:

Cefuroxime is not readily biodegradable nor inherently biodegradable. The phrase “Cefuroxime is potentially persistent” is thus chosen.


Bioaccumulation


Partitioning coefficient:

Log Dow = 0.80 at pH7. (TAD 3.02) (Reference 3)


Log Dow at pH5 = 1.24

Log Dow at pH7 = 0.80


Justification of chosen bioaccumulation phrase:

Since log Dow < 4, the substance has low potential for bioaccumulation.


Excretion (metabolism)


Cefuroxime is not metabolised and is excreted by glomerular filtration and tubular secretion. (Reference 2)


PBT/vPvB assessment

Cefuroxime 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). Cefuroxime does not fulfil the criteria for PBT and/or vBvP based on a log Dow < 4.


Please, also see Safety data sheets on http://www.msds-gsk.com/ExtMSDSlist.asp


References


  1. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.


  2. Pharmacokinetic properties: Metabolism and Elimination. Summary of Product Characteristics Zinnat (Cefuroxime) Suspension. GlaxoSmithKline, July2008.


  3. Material Safety Data Sheet for Zinnat (Cefuroxime) tablets. SDS number 110539. GlaxoSmithKline plc, July 2008.