Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.011 mg/L

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
4 184.4 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
418.4 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:
833.5 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

The toxicity potential of the substance to the aquatic organisms was evaluated by considering available data on Similar Substance 01, due to the absence of data for the target substance. Justification for Read Across is given in Section 13 of IUCLID.

The aquatic toxicity studies include the short-term toxicity to fish and to aquatic invertebrates, the toxicity to aquatic algae and the toxicity to microorganisms. It is worth saying that effect levels were above the water solubility of the substance. The following results are obtained:

Fish

LC50 (96 h)> 71 mg/l (measured)

Daphnia

EC50 (24h) = 11 mg/l (nominal)

Algae

EC50 (72 h) = 33.9 mg/l (nominal)

Microorganisms

IC50 (3 h) > 100 mg/l (nominal)

Conclusion on classification

Effect levels for all aquatic organisms were above the water solubility of the substance and therefore the substance is not considered to exhibit an aquatic toxicity potential. The use of solvents/dispersants rendered the substance more water soluble and thus more bioavailable to test organisms; the effect levels obtained are the worst case assumption since they are quite above the water solubility of the substance (<1 mg/l).

Classification for Acute Aquatic Toxicity or for Chronic Toxicity Category 1, 2 or 3 is not proposed. According to the CLP Regulation (EC) No. 1272/2008, the substance could be classified in Chronic Category 4 - safety net, but due to the fact that the substance is readily biodegradable and the effect levels are above the water solubility, no classification for aquatic toxicity is adopted.