Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
4.6 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
46 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.46 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.018 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.002 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.904 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
33.3 mg/kg food
Assessment factor:
30

Additional information

The following values are available from the ecotoxicity section:

LC50 96h Danio rerio: > 100 mg/L

NOEC 96h Danio rerio: > 100 mg/L

 

EC50 48h Daphnia magna: 86 mg/L

NOEC 48h Daphnia magna: 59 mg/L

 

EC50 72h Pseudokirchnerella subcapitata: 4.6 mg/L (biomass)

EC50 72h Pseudokirchnerella subcapitata: 17.7 mg/L (biomass)

NOEC 72h Pseudokirchnerella subcapitata: < 1 mg/L (biomass)

NOEC 72h Pseudokirchnerella subcapitata: < 1mg/L (biomass)

 

NOEC 3h activated sludges = 100 mg/L

EC10 3h activated sludges = 90 mg/L (95% Confidence interval 63 – 120 mg/L)

EC50 3h activated sludges = 6200 mg/L extrapolated (95 % Confidence interval 4000 – 9900 mg/L)

PNECs were derived according to ECHA REACH guidance (R.10).

Conclusion on classification

According to Regulation (EC) n- 1272/2008, Phenethylammonium salt of fosfomycin is classified for its environmental hazard as Aquatic Chronic 2, H411.