Miljöpåverkan
Miljöinformationen för dimetylfumarat är framtagen av företaget Biogen Sweden för Tecfidera
Miljörisk:
Användning av dimetylfumarat har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning:
Dimetylfumarat bryts ned i miljön.
Bioackumulering:
Dimetylfumarat 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 = 0.0214 µg/L
Where:
A = 155.9 kg (sales data for Sweden in 2022).
R = 0% removal rate. In this assessment 0% is used as a conservative value.
P = 10,000,000 (default value for number of inhabitants in Sweden)
V= 200 L/day (wastewater per capita per day, default value)
D = 10 (dilution, default value)
Predicted No Effect Concentration (PNEC)
Ecotoxicological studies
Algae (Raphidocelis subcapitata formally Pseudokirchneriella subcapitata) (OECD 201) (Ref. I):
EC50 72 h (growth rate) = 1.8 mg/L
NOEC (growth rate) = 0.037 mg/L
Crustacean (Daphnia magna):
Chronic toxicity (OECD 211) (Ref. I)
NOEC 21 days (reproduction) = 0.0559 mg/L
Fish (Pimephales promelas):
Chronic toxicity (OECD 210) (Ref. I)
NOEC 28 days (hatching and post-hatch survival) = 0.0457 mg/L
PNEC = 3.7 μg/L (an assessment factor of 10 is applied to the lowest NOEC from the base set of three long-term toxicity tests. In this case the NOEC of 37 μg/L for growth inhibition of the algae R. subcapitata)
Environmental risk classification (PEC/PNEC ratio)
PEC/PNEC = 0.0214/3.7 = 0.00578, i.e. PEC/PNEC ≤ 0.1 which justifies the phrase "Use of dimethyl fumarate has been considered to result in insignificant environmental risk."
Degradation
Biotic degradation
Ready degradability:
63% degradation in 5 days (OECD 301B CO2 Evolution Test). (Ref. I)
Justification of chosen degradation phrase:
Since > 60% biodegradation was achieved within five days of test initiation, dimethyl fumarate can be considered readily biodegradable. The degradation phrase should be: “Dimethyl fumarate is degraded in the environment.”
Bioaccumulation
Partitioning coefficient:
Log Kow= 0.77 (Ref I).
Justification of chosen bioaccumulation phrase:
Since log Kow < 4, the substance has low potential for bioaccumulation.
Excretion (metabolism)
In humans, dimethyl fumarate is extensively metabolised with less than 0.1% of the dose excreted as unchanged dimethyl fumarate in urine. Exhalation of CO2 is the primary route of dimethyl fumarate elimination accounting for 60% of the dose. Renal and faecal elimination are secondary routes of elimination, accounting for 15.5% and 0.9% of the dose respectively. Primary active metabolite is monomethyl fumarate (Ref II).
References
I. WCA (2021) Environmental risk assessment for Tecfidera. Final report.
II. Tecfidera SmPC, http://www.ema.europa.eu
III. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment.
http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.html.