Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.001 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
10 mg/kg sediment dw

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
8.18 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1.33 mg/kg food
Assessment factor:
300

Additional information

In CSR the PNEC aqua ( freshwater) was extrapolated from acute EC50 for daphnia, applying an AF=1000 and PNEC =1,07E-04 mg/L.

The new long term toxicity test for daphnia was performed with result of NOEC for daphnia 0,054 mg/L. This value was used for recalculation of PNEC aqua(freshwater)= 5,4E-04 mg/L.

Conclusion on classification

Dangerous to the environment

R50/53: Very toxic to aquatic organisms, may cause long -term adverse effects in the aquatic environment.

The ecotoxicity data submitted for the first notification suggest that the substance is highly toxic to fish, daphnia, algae, however additional ecotoxicity data for Dastib 845 indicate that the chemical is not toxic to fish and algae up to its apparent limit of solubility in water. Acording the expert statement submitted by notifier aquatic toxicity in these tests may be of a physico-chemical nature of the test substance and not due to classic aquatic toxicity.