Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.245 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
2.45 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.025 mg/L
Assessment factor:
10 000

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The PNECs listed are based on toxicity studies performed on losartan potassium salt, which has a solubility much greater than Losartan free acid (500,000 mg/L vs 4.8 mg/L at 20 deg C). However, given that the tests with losartan potassium salt have NOEC and LC50 values > 100 mg/L, it is predicted that aquatic toxicity studies with LFA would result in no toxic effects at the solubility limit and that the read-across to losartan potassium provides a conservative way of evaluating effects on the environment.

Conclusion on classification