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) = 1.5*10^-6*A(100-R)

PEC = 1,29 μg/L

Where:

A = 8 578,20 kg (total amount API in Sweden year 2011, data from IMS Health).

R = removal rate = 0% (no data available)

P = number of inhabitants in Sweden = 9*10⁶

V (L/day) = volume of waste water 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)

Ecotoxicological studies

Green algae (Scenedesmus subspicatus) (ref. 2)

EC₅₀ 72 hours (reproduction): > 100 mg/L (OECD 201)

Crustacean (Daphnia magna) (ref. 3)

EC₅₀ 24 hours (immobility): 684 mg/L (OECD, 1980, (slightly modified))

Crustacean (Daphnia magna) (ref. 4)

EC₅₀ 48 hours (immobility): 160 mg/L (OECD, 1984)

Crustacean (Ceriodaphnia dubia) (ref. 5)

LC₅₀ 48 hours: 57 mg/L (USEPA, 2002a, static)

LC₅₀ 7 days: 47 mg/L (USEPA, 2002a, static-renewal)

IC₅₀ 7 days (reproduction): 44 mg/L (USEPA, 2002a, static-renewal)

IC₂₅ 7 days (reproduction): 40 mg/L (USEPA, 2002a, static-renewal)

Freshwater fish (Pimephales promelas) (ref. 5)

LC₅₀ 48 hours: 97 mg/L (USEPA, 2002a, static)

LC₅₀ 7 days: 57 mg/L (USEPA, 2002a, static-renewal, slightly modified)

IC₅₀ 7 days (growth): 71 mg/L (USEPA, 2002a, static-renewal, slightly modified)

IC₂₅ 7 days (growth): 50 mg/L (USEPA, 2002a, static-renewal, slightly modified)

For the calculation of PNEC, ecotoxicological data for the most sensitive species, Ceriodaphnia dubia, is used. Since no NOEC is available, the long-term IC25 is used. An assessment factor (AF) of 1000 is applied, in accordance with the ECHA guideline (Ref. 1 chapter R.10).

PNEC is calculated as IC₂₅(Ceriodaphnia dubia)/1000 (AF)

PNEC = 40 μg/L

Environmental risk classification (PEC/PNEC ratio)

PEC/PNEC = 0,03

PEC/PNEC < 0,1 which justifies the phrase “Use of Caffeine has been considered to result in insignificant environmental risk”.

Degradation

Concerning biodegradation there is only a not valid study available for caffeine. However, for the structurally analogous compound theophylline there is a test on ready biodegradability available from which it can be concluded that this substance is readily biodegradable (OECD 301 A, 90-100% after 22 days, >90% at the end of the 10-day window). As the two substances differ only by one methyl group it can be concluded with high probability that also the substance caffeine is readily biodegradable. (Ref. 2)

Available degradation data are not sufficient to determine degradability for caffeine in accordance with the FASS guideline, and caffeine is assigned the phrase “The potential for persistence of caffeine cannot be excluded, due to lack of data”.

Bioaccumulation

An experimentally derived Log K_ow of -0,07 (unknown method) (Ref. 6) indicates that Caffeine has low potential for bioaccumulation.

Log K_ow<4 which justifies the phrase “Caffeine has low potential for bioaccumulation”.

Excretion (metabolism)

Caffeine is metabolized almost completely in the liver through oxidation, demethylation and acetylation. Caffeine is excreted through urine as metabolites and only approximately 1% as the unchanged substance. (Ref. 7)

References:

1. ECHA, European Chemicals Agency. Guidance on information requirements and chemical safety assessment. Ver 2.1, 2011. http://echa.europa.eu/documents/10162/13643/information_requirements_r2_en.pdf

2. OECD SIDS (Screening Information Data Set) Initial Assessment Report: Caffeine, Paris 2002, UNEP Publication.

3. Lilius H et al. (1994), Aquatic Toxicology 30 p47-60

4. Calleja MC et al. (1994), Archives of Environmental Contamination and Toxicology 26 p69-78

5. Moore MT et al. (2008), Archives of Environmental Contamination and Toxicology 54 p31-35

6. Hansch C et al. (1994), ChemID+, US National Library of Medicin, National Institutes of Health, http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp

7. SPC (Summary of Product Characteristics) Anervan Novum, 2011-10-14, FASS.se

Detaljerad miljöinformation

Enligt den europeiska läkemedelsmyndigheten EMA:s riktlinjer för miljöriskbedömningar av läkemedelssubstanser (EMA/CHMP/SWP/4447/00), är vitaminer, elektrolyter, aminosyror, peptider, proteiner, kolhydrater, lipider, vacciner och växtbaserade läkemedel undantagna då de inte bedöms medföra någon betydande risk för miljön.