Miljöpåverkan
Miljöinformationen för klindamycin är framtagen av företaget GlaxoSmithKline för Duac®
Miljörisk:
Risk för miljöpåverkan av klindamycin kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att klindamycin är persistent, då data saknas.
Bioackumulering:
Klindamycin 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) = 1.37*10-6*A(100-R)
PEC = 0.144 μg/L
Where:
A = 1,049.85 kg (total sold amount API in Sweden year 2020, data from IQVIA). Total volume of Clindamycin phosphate = 79.07 = 66.42 clindamycin free base. Total volume of Clindamycin hydrochloride 983.43 = 904.66 clindamycin free base. Total volume of Clindamycin palmitate hydrochoride = 17.63 = 10.83 clindamycin free base. Total Clindamycin = 66.42 + 983.43 + 10.83 = 1,049.85.
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)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Green Algae (Pseudokirchneriella subcapitata):
EC50 (inhibition of growth rate) = 4.1 μg/L (OECD 201) (Reference 3)
EC10 = 0.98 μg/L
Water flea (Daphnia magna):
Acute toxicity
No data
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 clindamycin 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 Clindamycin is cannot be excluded, due to lack of data” is thus chosen.
Bioaccumulation
Partitioning coefficient:
Log Dowcalc at pH 5 = -1.47 (QSAR) (Reference 4)
Log Dowcalc at pH 7 = 0.38
Log Dowcalc at pH 9 = 1.02
Justification of chosen bioaccumulation phrase:
Since log Kow < 4 at pH 7, the substance has a low potential for bioaccumulation.
Excretion (metabolism)
In an open-label study of 24 patients with moderate-to-severe acne vulgaris, approximately 4 grams of Duac Once Daily 10 mg/g + 30 mg/g Gel was applied once daily for 5 days to the face, upper chest, upper back, and shoulders. Geometric mean maximal plasma clindamycin exposure (Cmax) on Day 5 was 0.961 ng/mL with an AUC∞ of 12.9 ng*hr/mL.
In a maximised percutaneous absorption study the mean plasma clindamycin levels during a four-week dosing period for clindamycin 10 mg/g + benzoyl peroxide 50 mg/g gel were negligible (0.043 % of applied dose). (Reference 2).
PBT/vPvB assessment
Clindamycin 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). Clindamycin does not fulfil the criteria for PBT and/or vBvP based on log Dow < 4.
Please, also see Safety data sheets on http://www.msds-gsk.com/ExtMSDSlist.asp
References
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ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.
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Pharmacokinetic properties: Metabolism and Elimination. Summary of Product Characteristics DUAC once Daily 10mg/g and 30mg/g Gel. Stiefel, March 2018.
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Instant J Chem Log P and LogD. Sep 2012. Chemaxon Inc.