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 = 2.70 x10^-4 μg/L

Where:

A = 1.77kg (total sold amount API in Sweden year 2019, 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)

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

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Algae:

No data

Water flea (Daphnia magna):

Acute toxicity

EC50 48 h (immobility) > 430 μg/L (TAD 3.11/OECD 202) (Reference 2)

NOEC = 430 μg/L

Chronic toxicity

No data

Fish:

Acute toxicity

No data

Chronic toxicity

No data

Other ecotoxicity data:

Microorganisms in activated sludge:

EC50 3 h (inhibition) > 100,000 μg/L @ 3 hrs (OECD 209) (Reference 3)

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 clobetasone butyrate cannot be excluded, since there is not sufficient ecotoxicity data available.

Degradation

Biotic degradation

Ready degradability:

No data

Inherent degradability:

<20% degradation in 28 days, primary biodegradation (OECD 302B) (Reference 4)

Abiotic degradation

Hydrolysis:

No data

Photolysis:

No data

Justification of chosen degradation phrase:

Clobetasone butyrate is not readily degradable or inherently degradable. The phrase “Clobetasone butyrate is potentially persistent” is thus chosen.

Bioaccumulation

Partitioning coefficient:

Log Pow = 3.63 (TAD 3.02) (Reference 5)

Log Pow_calc = 3.5 (Reference 6)

Justification of chosen bioaccumulation phrase:

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

Excretion (metabolism)

Emovat is a topical preparation and therefore pharmacokinetic properties and metabolism are not applicable.

PBT/vPvB assessment

Clobetasone butyrate does not fulfil the criteria for PBT and/or vPvB

All three properties, i.e. ‘P’, ‘B’ and ‘T’ are required in order to classify a compound as PBT (Reference 1).

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. Stewart KM, Smyth DV and Kent SJ. Clobetasone 17 Butyrate: Acute Toxicity to Daphnia magna. Report No. BL7706/B. Brixham Environmental Laboratory Limited, November 2004.

3. Swarbrick RH and Smyth DV. Clobetasone 17 Butyrate: Effect on the Respiration Rate of Activated Sludge. Report No. BL7707/B. Brixham Environmental Laboratory Limited, October 2004.

4. Stewart KM, Smyth DV and Kent SJ. Clobetasone 17 Butyrate: Determination of Inherent Biodegradability (Zahn-Wellens Test). Report No. BL7708/B. Brixham Environmental Laboratory Limited, November 2004.

5. MSDS ID 85984 Clobetasol propionate. GlaxoSmithKline plc, December 2011.

6. ACD /LogD. May 2012. Advanced Chemistry Development, Inc.