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

PEC = 0.002 μg/L

Where:

A = 16 kg (total sold amount API in Sweden year 2021, data from IQVIA) (Ref. I)

R = 0 % removal rate (worst case assumption)

P = number of inhabitants in Sweden = 10 *10⁶

V (L/day) = volume of wastewater per capita and day = 200 (ECHA default) (Ref. II)

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

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

No data available.

Environmental risk classification

Since no data are available the phrase “Risk of environmental impact cannot be excluded for rocuronium bromide since no ecotoxicity data are available” is justified.

Degradation

No data available.

Justification of chosen degradation phrase:

Since no data are available the phrase “The potential for persistence of rocuronium bromide cannot be excluded due to lack of data” is justified.

Bioaccumulation

Partioning coefficient:

log K_ow = 0.5 at 20°C (unknown method)(Ref. III)

Justification of chosen bioaccumulation phrase:

Since the log K_ow < 4, the phrase “Rocuronium bromide has low potential for bioaccumulation” is justified.

References

1. Data from IQVIA ”Consumption assessment in kg for input to environmental classification - updated 2022 (data 2021)”.

2. 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

3. Organon, 2004. General Properties, Rocuronium bromide. Organon R&D Report NL0048689.