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) = 1.37*10^-6*A(100-R)

PEC = 1.25*10^-4 μg/L

Where:

A = 0.91 kg (total amount API of bromocriptine mesilate 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)

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

Ecotoxicological studies

No ecotoxicological data available.

Degradation

No degradation data available.

Bioaccumulation

A computed Log P of 3.8 (XLogP3) (Ref. 3) indicates that bromocriptine has low potential for bioaccumulation.

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

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. U.S. National Library of Medicine, National Center for Biotechnology Information. PubChem Compound Database; CID=31101, http://pubchem.ncbi.nlm.nih.gov/compound/31101