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Fluoresceinnatrium Bausch & Lomb

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  • Vad är miljöinformation?

Miljöinformation

Miljöpåverkan (Läs mer om miljöpåverkan)

fluorescein

Miljörisk: Användning av fluorescein har bedömts medföra försumbar risk för miljöpåverkan.
Nedbrytning: Det kan inte uteslutas att fluorescein är persistent, då data saknas.
Bioackumulering: fluorescein har låg potential att bioackumuleras.


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Detaljerad miljöinformation

Environmental Risk Classification


Predicted Environmental Concentration (PEC)


PEC is based on following data:


PEC (µg/L) = (A*109*(100-R))/(365*P*V*D*100)


PEC (µg/L) = 1.5*10-6*A*(100-R)


A (kg/year) = total sold amount API in Sweden year 2016, data from Quintiles IMS.

R (%) = removal rate (due to loss by adsorption to sludge particles, by volatilization,

hydrolysis or biodegradation) = 0 if no data is available.

P = number of inhabitants in Sweden = 9 *106
V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref.1)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref.1)

(Note: The factor 109 converts the quantity used from kg to μg).


A =4,7858 kg. The total sold amount of fluorescein natrium in Sweden year 2016, data from Quintiles IMS. (Ref.2)

R =0


PEC = 1.5 * 10-6 *4,7858*(100-0)= 0,0007179 µg/L


According to the European Medicines Agency guideline on environmental risk assessment of medicinal products (EMA/CHMP/SWP/4447/00), use of fluorescein is unlikely to represent a risk for the environment, because the predicted environmental concentration (PEC) is below the action limit 0.01 µg/L.


Predicted No Effect Concentration (PNEC)


The 48-h LC50 of fluorescein sodium salt to the crustacean Daphnia pulex was estimated to 337 mg/L using acute and chronic level toxicological endpoints. (Ref. 3)


An assessment of fluorescein's ecotoxicity was performed using the Structure activity relationship (SAR) technique, which is not a standardized test of obtaining ecotoxicity data. By using this technique the 96-h LC50 to fish (not specified species) was estimated to 2200 mg/L, the 48-h LC50 to crustacean Cladocera was 165 mg/L and the 96-h EC50 to green algae was <10 mg/L of fluroescein. (Ref.4)


The PNEC value is based on the acute toxicity for the most sensitive species, green algae, of three short-term toxicity. An assessment factor of 1000 is applied, in accordance with ECHA guidance. (Ref. 1)


PNEC= 10 000 µg/L/1000= 10 µg/L


Environmental risk classification (PEC/PNEC ratio)


PEC/PNEC = 0,0007179/10= 7,2 * 10-5 , i.e PEC/PNEC ≤ 0,1 which justifies the phrase ”Use of fluorescein has been considered to result in insignificant environmental risk”.


It must be noticed that the PNEC value and the PEC/PNEC ratio are calculated from exotoxicity data using the SAR technique.


Degradation


The potential for persistence of fluorescein cannot be excluded, due to lack of data.


Bioaccumulation


Fluorescein has an estimated log Kow = 3.35 (method: Estimation Programs Interface). (Ref.5)


The Log Kow is thus <4 and the BCF value is <500 which indicates that “Fluorescein has low potential for bioaccumulation”.


References


  1. ECHA, European Chemicals Agency.

    October 2012 Version: 2.1 Guidance on information requirements and chemical safety assessment. http://guidance.echa.europa.eu/docs/guidance_document/information_requirements_en.htm

  2. Data from Quintiles IMS ”Consumption assessment in kg for input to environmental classification - updated 2017”.

  3. Walthall, W.K. and Stark, J.D. 1999. The acute and chronic toxicity of two xanthene dyes, fluorescein sodium salt and phloxine B, to Daphnia pulex. Environmental Pollution. 104, 207-215.

  4. Field, M.S., Wilhelm, R.G., Quinlan, J.F. and Aley, T.J. 1995. An assessment of the potential adverse properties of fluorescent tracer dyes used for groundwater tracing. Environmental monitoring and assessment. 38,75-96.

  5. Fluorescein, National Center for Biotechnology Information. Pubchem Compound Database; http://pubchem.ncbi.nlm.nih.gov/compound/fluorescein#section=Vapor-Pressure (accessed June 30, 2017), data from US EPA; Estimation Program Interface (EPI) Suite. Ver.4.0. Jan, 2009.