Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.105 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
1.05 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
12.9 µg/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:
25.3 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

Acute hazard category

There are adequate short-term studies available covering three trophic levels, i.e. algae, daphnia and fish. According to Regulation (EC) No 2008/1272, the submission substance does not need to be classified for aquatic acute hazards, because available EC50 values are > 1 mg/L, i.e. the most sensitive EC50 value is 48h-EC50 (Daphnia magna, immobilisation) = 1.05 mg/L.

 

Chronic hazard category

There is one adequate long-term toxicity effect concentration available, i.e. for algae. The derived effect concentration is 72h-NOEC (Selenastrum capricornutum, growth rate) = 0.66 mg/L. The submission substance is not rapidly biodegradable. Following the classification system of Regulation (EC) No 2008/1272, the submission substance must be classified for aquatic hazard category chronic 2, based on both acute derived effect concentrations and chronic effect concentrations (i.e. 1 mg/L < EC50 < 10 mg/L, 0.1 mg/L < NOEC < 1 mg/L, not rapidly biodegradable).

In conclusion, the submission substance is classified for aquatic hazard Category Chronic 2, 'toxic to aquatic life with long-lasting effects' (H411).