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) = 1.37*10^-6*A(100-R)

PEC = 1.14 x10^-4 μg/L

Where:

A = 0.83 kg (total sold amount API free base in Sweden year 2022, data from IQVIA). Total volume of Mupirocin calcium = 0.19 = 0.16 Mupirocin free base. Total Mupirocin = 0.16 + 0.67 = 0.83.

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 = 10 *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)

According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of Mupirocin is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) at the time of registration was below the action limit 0.01 μg/L. (Reference 6)

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae:

No data

Water flea (Daphnia magna):

Acute toxicity

EC50 48 h (immobility) > 1,000,000 μg/L (TAD 3.11/OECD 202) (Reference 4)

NOEC = 1,000,000 μg/L

Chronic toxicity

No data

Fish

Acute toxicity

No data

Chronic toxicity

No data

Other ecotoxicity data:

Microorganisms in activated sludge:

No data

PNEC cannot be calculated because data is not available for all three (algae, crustacean and fish) of the toxicity endpoints.

Environmental risk classification (PEC/PNEC ratio)

Risk of environmental impact of mupirocin cannot be excluded since there is not sufficient ecotoxicity data available.

Degradation

Biotic degradation

Ready degradability:

No data

Inherent degradability:

No data

Abiotic degradation

Hydrolysis:

No data

Photolysis:

No data

Justification of chosen degradation phrase:

The phrase “The potential for persistence of Mupirocin is cannot be excluded, due to lack of data” is thus chosen.

Bioaccumulation

Partitioning coefficient:

Log Dow = 2.28 at pH7 (TAD 3.02) (Reference 3)

Log Dow at pH5 = 0.6

Log Dow at pH7 = 2.28

Log Dow_calc at pH 5 = 2.06 (QSAR) (Reference 5)

Log Dow_calc at pH 7 = 0.30

Log Dow_calc at pH 9 = -0.99

Justification of chosen bioaccumulation phrase:

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

Excretion (metabolism)

Following intravenous or oral administration, mupirocin is rapidly metabolized. The

principle metabolite, monic acid, is eliminated by renal excretion, and demonstrates no antibacterial activity. In a study conducted in seven healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid. The pharmacokinetics of mupirocin has not been studied in individuals with renal insufficiency (Reference 2).

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. Product Information: Bactroban, mupirocin GlaxoSmithKline, Research Triangle Park, NC, 2001.

3. MSDS ID 147. Mupirocin. GlaxoSmithKline plc, July 2011.

4. Pell D. Mupirocin calcium: Acute Toxicity to Daphnia magna. Report No. BRL1129M/86549. Huntingdon Life Sciences Limited, June 1986.

5. Instant J Chem Log P and LogD. Sep 2012. Chemaxon Inc.

6. European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00)