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Evrysdi

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Miljöinformation
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Förmånsstatus
Roche

Pulver till oral lösning 0,75 mg/ml
(Ljusgult, gult, grågult, gröngult eller ljusgrönt pulver)

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ATC-kod: M09AX10
Utbytbarhet: Ej utbytbar
Läkemedel från Roche omfattas av Läkemedelsförsäkringen.
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Miljöinformation

Miljöpåverkan

Risdiplam

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


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Detaljerad miljöinformation

Identification and characterisation

Chemical name: Risdiplam

CAS number: 1825352-65-5 [1]

Molecular weight: 401,4717 [1]

Remark: -

Brand name: Evrysdi [1]


Physico-chemical properties

Aqueous solubility

0.406 mg/l at pH 7.7 (20 °C) (OECD 105) [1]

Dissociation constant, pKa

3.78 (pK1) (25 °C, pH-metric pKa method) [1]
 

6.62 (pK2) (25 °C, pH-metric pKa method) [1]

Vapour pressure

1.46 × E–8 Pa (25 °C) QSAR (EPISuite)

KH

1.28 × 10-11 Pa m3 mol-1 QSAR (EPISuite)

Predicted Environmental Concentration (PEC)

PEC is calculated according to the formula:

PEC (µg/l) = (A x 1'000'000'000 x (100 - R)) / (365 x P x V x D x 100) = 1.37 x 10-6 x A x (100 - R) = 0.00001 µg/l

Where:

A Sold quantity = 0.07188 kg/y saled data from IQVIA/LIF - kg consumption 2022

R Removal rate = 0 % Default [2]

P Population of Sweden = 10 000 000

V Volume of Wastewater = 200 l/day Default [2]

D Factor for Dilution = 10 Default [2]


Predicted No Effect Concentration (PNEC)

Ecotoxicolocigal Studies


Green alga (Desmodesmus subspicatus): [3]

72 h ErC50 (growth rate) >100 mg/l nominal concentration (OECD 201)

72 h EyC50 (yield) >100 mg/l nominal concentration (OECD 201)

72 h NOEC = 100 mg/l nominal concentration (OECD 201)

72 h NOEC = 0.344 mg/l geometric mean concentration (OECD 201)


Water-flea (Daphnia magna): [4]

48 h EC50 (immobilisation) >100 mg/l nominal concentration (OECD 202)

48 h NOEC (immobilisation) = 100 mg/l nominal concentration (OECD 202)

48 h NOEC (immobilisation) = 0.280 mg/l geometric mean concentration (OECD 202)


Zebrafish (Danio rerio): [5]

96 h LC50 (mortality) >100 mg/l nominal concentration (OECD 203)

96 h NOEC (mortality) = 100 mg/l nominal concentration

96 h NOEC (mortality) = 0.821 mg/l mean measured concentration


Micro-organisms (activated sludge): ]6]

14 d NOEC (toxicity control) = 35 mg/l (OECD 301 F)


PNEC Derivation

The PNEC is based on the following data:

PNEC (μg/l) = lowest acute LC50/EC50, where 1000 is the assessment factor used. An EC50 of >0.344 mg/l (i.e. 344 μg/l) for algae has been used for this calculation.

PNEC = 344 mg/l / 1000 = 0.344 μg/l


Environmental Risk Classification (PEC/PNEC Ratio)

PEC Predicted Environmental Concentration = 0.00001 μg/l

PNEC Predicted No Effect Concentration = 0.344 μg/l

Ratio PEC/PNEC = 0.00003

PEC/PNEC = 0.00001/0.344 = 0.00003 for Risdiplam which justifies the phrase 'Use of Risdiplam has been considered to result in insignificant environmental risk.'


Degradation

Biotic Degradation

Ready biodegradability: [6]

0% after 28 days of incubation BOD/ThOD (OECD 301 F)

90% after 28 days of incubation DOC/TOC (OECD 301 F)

Risdiplam is not readily biodegradable. This justifies the phrase 'Risdiplam is potentially persistent.'


Bioaccumulation/Adsorption

logDOW = 0.69 (pH 5, 22–23 °C) (OECD 107) [7]

logDOW = 2.37 (pH 7, 22–23 °C) (OECD 107) [7]

logDOW = 2.63 (pH 9, 22–23 °C) (OECD 107) [7]

logDOW = ≤-1.08 (pH 5, 25 °C) (OECD 117) [8]

logDOW = 0.58 (pH 7, 25 °C) (OECD 117) [8]

logDOW = 0.81 (pH 9, 25 °C) (OECD 117) [8]


Risdiplam has low potential for bioaccumulation since the logDOW (at pH 7) is <4.


References

  1. F. Hoffmann-La Roche Ltd (2021): Environmental Risk Assessment Summary for Risdiplam. https://www.roche.com/sustainability/environment/environmental-risk-assessment-downloads.htm

  2. European Medicines Agency (EMA) (2006/2015): Guideline on the environmental risk assessment of medicinal products for human use. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP), 01 June 2006, EMA/CHMP/SWP/447/00 corr 2

  3. Arcadis Schweiz Ltd, on behalf of F. Hoffmann-La Roche Ltd, Basel, Switzerland (2018): SIP09. Fresh water algal growth inhibition test with Desmodesmus subspicatus; limit test with 100 mg/l; OECD 201. Study no. A17-01121

  4. Arcadis Schweiz Ltd, on behalf of F. Hoffmann-La Roche Ltd, Basel, Switzerland (2018): SIP09. 48-Hour acute toxicity to Daphnia magna; OECD 202. Study no. A17-01122

  5. Arcadis Schweiz Ltd, on behalf of F. Hoffmann-La Roche Ltd, Basel, Switzerland (2018): SIP09. 96-Hour acute toxicity to Danio rerio (Zebrafish); OECD 203. Study no. A17-01123

  6. Arcadis Schweiz Ltd, on behalf of F. Hoffmann-La Roche Ltd, Basel, Switzerland (2018): SIP09. Ready biodegradability – evaluation of the aerobic biodegradability in an aqueous medium: manometric respirometry test; OECD 301 F. Study no. A17-01124

  7. Arcadis Schweiz Ltd, on behalf of F. Hoffmann-La Roche Ltd, Basel, Switzerland (2021): Risdiplam. Determination of the partition coefficient between 1-octanol and water by the shake flask method. Study no. A21-00135

  8. Arcadis Schweiz Ltd, on behalf of F. Hoffmann-La Roche Ltd, Basel, Switzerland (2018): SIP09. Determination of the partition coefficient between octanol and water (log POW) by high performance liquid chromatography (HPLC); OECD 117. Study no. A17-02241

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