Miljöpåverkan
Miljöinformationen för granisetron är framtagen av företaget hameln pharma för Granisetron Hameln
Miljörisk:
Risk för miljöpåverkan av granisetron kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning:
Det kan inte uteslutas att granisetron är persistent, då data saknas.
Bioackumulering:
Granisetron har låg potential att bioackumuleras.
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Detaljerad miljöinformation
Appendix 1 - Template for environmental information at www.fass.se
Miljörisk: Risk för miljöpåverkan av granisetron kan inte uteslutas då ekotoxikologiska data saknas.
Nedbrytning: Det kan inte uteslutas att granisetron är persistent, då data saknas.
Bioackumulering: Granisetron har låg potential att bioackumuleras.
Detailed background information
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 = 5.16*10-7 μg/L
Where:
A = 0.0622 kg (total sold amount API in Sweden year 2021, data from IQVIA).
R = 0 % removal rate (due to 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) (Ref. I)
D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. I)
Predicted No Effect Concentration (PNEC)
No ecotoxicological study results are available, hence the PNEC (μg/L) could not be estimated.
Environmental risk classification (PEC/PNEC ratio)
The PEC/PNEC ratio could not be calculated due to lack of data and therefore justifies the phrase: "Risk of environmental impact of granisetron cannot be excluded, since no ecotoxicity data are available".
However, according to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of granisetron is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 μg/L.
Degradation
No degradation data are available, hence justifies the phrase: "The potential for persistence of granisetron cannot be excluded, due to lack of data".
Bioaccumulation
Partitioning coefficient:
Log Pow = 1.9 (experimental by unknown method) (Ref II)
Justification for bioaccumulation phrase:
Since log Log P < 4, the substance has low potential for bioaccumulation.
Excretion (metabolism)
Granisetron is metabolized primarily in the liver by oxidation followed by conjugation. The major compounds are 7-OH-granisetron and its sulphate and glycuronide conjugates. Although antiemetic properties have been observed for 7-OH-granisetron and indazoline N-desmethyl granisetron, it is unlikely that these contribute significantly to the pharmacological activity of granisetron in man.Urinary excretion of unchanged granisetron averages 12% of dose while that of metabolites amounts to about 47% of dose. The remainder is excreted in faeces as metabolites.
References
I. ECHA, European Chemicals Agency. 2008 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm
II. Drugbank online. https://go.drugbank.com/drugs/DB00889. Retrieved 2022-06-23.
III. SmPC Granisetron Hameln 1 mg/ml koncentrat till injektions-/infusionsvätska, lösning. MA no. 25505 (2020-06-15).