Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.009

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001
Extrapolation method:
equilibrium partitioning method

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.007
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Conclusion on classification

Classification and labelling has been based upon the key information for the ecotoxicity endpoints. The results of these studies are as follows:

96 hour LOEC (fish): >5.70 mg/L (Hooftman and De Wolf, 2003)

48 hour EC50 (Daphnia): 0.21 mg/L (Hooftman and De Wolf, 2003)

72 hour EC50 (algae): 4.1 mg/L (Oldersma, Hanstveit & de Wolf, 2003)

It should also be considered that the substance does not meet the definition of a readily biodegradable substance (Hanstveit 2003).

The 48-hour EC50 (Daphnia) value presented by Hooftman and De Wolf, 2003, of 0.21 mg/L is suitable for use for classification and labelling and this meets the criteria under Directive 67/548/EEC and Regulation (EC) No 1272/2008 as follows:

Directive 67/548/EEC:

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

- Labelling:

-- N - dangerous for the environment

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

Regulation (EC) No 1272/2008:

- Classification: Hazardous to the aquatic environment

-- Aquatic Chronic 1 (Hazard statement: H410: Very toxic to aquatic life with long lasting effect.)

-- Aquatic Acute 1 (Hazard statement: H410: Very toxic to aquatic life.)

- Labelling:

-- Hazard pictogramm GHS09: environment

-- Hazard statement H410: Very toxic to aquatic life with long lasting effects. (Please note: where the hazard statement H410 is used on the label due to classification into Chronic hazard category 1, the hazard statement H400 shall not appear on the label.)