Detaljerad miljöinformation

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	=	0.0010634 μg/L
Where:
A	=	7.762716 kg (total sold amount API in the most recent sales data for Sweden (2020) was distributed by IQVIA in 2021)
R	=	X % 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 = 10 *106
V (L/day)	=	volume of wastewater per capita and day = 200 (ECHA default) (Ref. 1)
D	=	factor for dilution of wastewater by surface water flow = 10 (ECHA default) (Ref. 1)

Predicted No Effect Concentration (PNEC)

Ecotoxicological studies

Crustacean

Acute Toxicity to water fleas Daphnia magna (OECD 202) [Ref. 2]:

EC₅₀ 48 h: 66 mg/L (endpoint: not specified)

Fish

Acute Toxicity to Rainbow trout (OECD 203) [Ref. 2]:

LC₅₀ 96 h: > 100 mg/L (endpoint: not specified)

NOEC 96h: < 100 mg/L (endpoint: not specified)

Environmental risk classification (PEC/PNEC ratio)

Calculation of Predicted No Effect Concentration (PNEC)

Because not all data for each of the three trophic levels (fish, invertebrates and algae) are available, the PNEC cannot be calculated.

Conclusion for environmental risk:

Risk of environmental impact of Bosentan cannot be excluded since there is not sufficient ecotoxicity data available.

DEGRADATION

Biotic degradation

Ready biodegradation

0%, 28 days

Manometric Respirometry Test, OECD Test Guideline No. 301 F

Not readily biodegradable

(Ref. 2)

Inherent biodegradation

0%, 28 days

MITI Test II, OECD Test Guideline No. 302 C

Not inherently biodegradable

(Ref. 2)

Conclusion for degradation:

Bosentan is potentially persistent.

BIOACCUMULATION

Partition coefficient octanol/water

Data according open literature [Ref. 3]:

• ChemSpider reports:

  • ACD/LogD (pH 7.4): 1.53

Bioconcentration

Data according open literature [Ref. 3]:

• ChemSpider reports:

  • ACD/BCF (pH 7.4): 2.85

Conclusion for bioaccumulation:

Bosentan has low potential for bioaccumulation.

Excretion (metabolism)

No data available.

PBT/vPvB assessment

No data available.

References

1. 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

2. MSDS ‘Bosentan’; Actelion Pharmaceuticals Ltd., Gewerbestrasse 16, Allschwill (Switzerland), version 2, 01/10/2014.

3. ChemSpider 2019. http://www.chemspider.com/