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Mucoangin Citron

Sanofi AB

Sugtablett 20 mg
(rund, vit, platt på bägge sidor, med avfasade kanter, smak av citron)

Medel vid sjukdomar i strupe och svalg, lokalanestetika

Aktiv substans:
ATC-kod: R02AD
Läkemedel från Sanofi AB omfattas av Läkemedelsförsäkringen.
  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan

Ambroxol

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


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Detaljerad miljöinformation

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 = 0.0045 µg/L


Where:

A = 29.85580 kg (total sold amount API in Sweden year 2018, data from IQVIA).

R = 0 % removal rate.

P = number of inhabitants in Sweden = 9 *106

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (I)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (I)


Predicted No Effect Concentration (PNEC)


PNEC = 8.7 μg/L


The PNEC has been derived from the lowest relevant EC50 value of 8.7 mg/L (Scenedesmus subspicatus, 72 h, growth rate (preferred endpoint (II))). An assessment factor of 1000 is used based on the availability of acute toxicity studies for all trophic levels in accordance with ECHA Guidelines (I).


Ecotoxicological studies

Algae (Green algae, Scenedesmus subspicatus) (OECD 201, GLP), (III):

EC50 72h (biomass) = 2.4 mg/L (corresponding to 2.6 mg ambroxolhydroklorid/L)

NOEC 72h (biomass) = 0.42 mg/L (corresponding to 0.46 mg ambroxolhydroklorid/L)

EC50 72h (growth rate) = 8.7 mg/L (corresponding to 9.5 mg ambroxolhydroklorid/L)

NOEC 72h (growth rate) = 0.91 mg/L (corresponding to 1.0 mg ambroxolhydroklorid/L)


Crustacean (Water flea, Daphnia magna) (OECD 202, GLP), (III):

Acute toxicity

EC50 48h (immobilization)= 23.3 mg/L (corresponding to 25.6 mg ambroxolhydroklorid/L)

NOEC 48h (immobilization)= 4.2 mg/L (corresponding to 4.6 mg ambroxolhydroklorid/L)


Fish (Zebrafish, Danio rerio) (OECD 203, GLP, (V):

Acute toxicity

LC50 96 h (mortality) = 20.8 mg/L (corresponding to 22.8 mg ambroxolhydroklorid/L)

NOEC 96 h (increased ventilation) = 4.6 mg/L (corresponding to 10 mg ambroxolhydroklorid/L)


Other ecotoxicity data

EC50 for inhibition of active sludge (3 h, OECD 209, GLP) = 144.3 mg/L (VI).


Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0.0045/8.7 = 5.2 ×10-4, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase “Use of ambroxol has been considered to result in insignificant environmental risk.”


Degradation


Biotic degradation


Ready degradability:

In a 28 d ready biodegradability study in accordance with OECD Test Guideline 301D (GLP) 0 % biodegradation of Ambroxol was observed (VII). Based on these data ambroxol is not considered readily biodegradable.


Inherent degradability:

In a 28 d inherent biodegradability study in accordance with OECD Test Guideline 302B (GLP) 12 % biodegradation of Ambroxol was observed (VIII). Based on these data ambroxol is not considered inherently biodegradable.


Simulation studies:

No data on simulation studies.


Abiotic degradation

Hydrolysis: No data on hydrolysis

Photolysis: No data on photolysis.


Justification of chosen degradation phrase:

Ambroxol did not pass the ready degradation test (OECD 301D) or the inherent degradability test (OECD 302B). Data on abiotic degradation is lacking. Based on these data ambroxol is considered “potentially persistent”.


Bioaccumulation


Bioconcentration factor (BCF):

QSAR calculations using EPIWIN resulted in a BCF of 342 for Ambroxol and 3.2 as Ambroxolhydroklorid (IX).


Partitioning coefficient:

The n-octanol/water partition coefficient was determined at pH 5, pH 7 and pH 9 (OECD 122, GLP), (X) with the following results:

pH 5: -0.35; pH 7: 1.63; pH 9: 2.74


The n-octanol/water partition coefficient was determined in an OECD Guideline 117 (GLP) study showing a log Pow of 4.2 at pH 9 (XI).


Justification of chosen bioaccumulation phrase:

Based on the data from the OECD Guideline 122 study showing a log Pow <4 at pH 7, and the QSAR calculations, Ambroxol is considered to have “low potential for bioaccumulation”.


Excretion (metabolism)


Following oral administration of 14C-Ambroxol in humans the radioactivity was excreted mainly in urine (≈70% of administered oral dose): ≈50% glucoronides of the unchanged drug, ≈10% as glucoronides of the oxidized metabolites, dirbomoanthranilic acid, ≈10% as unchanged drug and a minor formylated cyclization product (XII; XIII). No information on the biological activity of the metabolites was provided.


PBT/vPvB assessment

Ambroxol is considered not to fulfil the criteria for PBT or vPvB.

References

I

European Chemicals Agency (ECHA), 2008. Guidance on information requirements and chemical safety assessment. Chapter R.10: Characterization of dose[concentration]-response for environment. http://echa.europa.eu/documents/10162/13632/information_requirements_r10_en.pdf

II

European Chemicals Agency (ECHA), 2014. V2.0. Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7b: Endpoint specific guidance. http://echa.europa.eu/documents/10162/13632/information_requirements_r7b_en.pdf

III

Boehringer Ingelheim GmbH internal report No U02-1603

IV

Boehringer Ingelheim GmbH internal report No U02-1601

V

Boehringer Ingelheim GmbH internal report No U03-1254

VI

Boehringer Ingelheim GmbH internal report No U08-0060-01

VII

Boehringer Ingelheim GmbH internal report No U02-1604

VIII

Boehringer Ingelheim GmbH internal report No U03-1258

IX

Boehringer Ingelheim Environmental Risk Assessment of Ambroxol

X

Boehringer Ingelheim GmbH internal report No U08-0049-01

XI

Boehringer Ingelheim GmbH internal report No U02-1600

XII

Boehringer Ingelheim GmbH internal report No P00-00270,

XIII

Boehringer Ingelheim GmbH internal report No P77-0553