Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for predators

Secondary poisoning

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

Additional information

All assessment and conversion factors used in the above PNEC calculations were taken from the ECHA guidance document "Guidance on information requirements and chemical safety assessment; Chapter R.10: Characterisation of dose [concentration]-response for environment" along with appropriate equations and methodologies.

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): >100 mg/l (Goodband, 2004; SPL project number: 1666/059)

48 hour EC50 (Daphnia): 75 mg/l (Goodband, 2004; SPL project number: 1666/058)

72 hour EC50 (algae): >1000 mg/l (Vryenhoef, 2004; SPL project number: 1666/057)

It should also be considered that the substance does not meet the definition of a readily biodegradable substance according to the key studies in section 5.2.1.

The 48-hour EC50 (Daphnia) value presented by Goodband, 2004 of 75 mg/l is suitable for use for classification and labelling and this meets the criteria under 67/548/EEC and EC Regulation 1272/2008 as follows:

67/548/EEC:

R52 and R53: Harmful to aquatic organisms and May cause long-term adverse effects to the aquatic environment.

EC Regulation 1272/2008:

Hazardous to the aquatic environment, Chronic: Category 3; H412 Harmful to aquatic life with long lasting effects.