Detaljerad miljöinformation

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

PEC = 0.023 μg/L

Where:

A = 156.02 kg (total amount API of cloxacillin sodium (monohydrate) in Sweden year 2020, data from IQVIA) (Ref. 1)

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

P = number of inhabitants in Sweden = 10*10⁶

V (L/day) = volume of waste water per capita and day = 200 (ECHA default) (Ref. 2)

D = factor for dilution of waste water by surface water flow = 10 (ECHA default) (Ref. 2)

Ecotoxicological studies

No ecotoxicological data available.

Degradation

No degradation data available.

Bioaccumulation

An experimentally derived Log P of 2.48 (unknown method) (Ref. 3) indicates that cloxacillin has a low potential for bioaccumulation.

Log P < 4 which justifies the phrase “Cloxacillin has low potential for bioaccumulation”.

Excretion (metabolism)

Elimination of cloxacillin occurs mainly in the kidneys via tubular secretion and glomerular filtration. Within 6 hours, 30-50 % of an orally administered dose is excreted with the urine (Ref. 4).

References:

1. Data from IQVIA "Consumption assessment in kg for input to environmental classification" – updated 2021 (data 2020)

2. 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

3. Sangster (1994) ChemID+, US National Library of Medicin, National Institutes of Health, http://chem.sis.nlm.nih.gov/chemidplus/chemidheavy.jsp

4. SPC (Summary of Product Characteristics) Ekvacillin, 2018-07-13, FASS.se.