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):
0.005 mg/L

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.05 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.005 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.041 mg/kg soil dw
Assessment factor:
10
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

For derivation of the PNECaqua (freshwater), PNECaqua (marine water) and PNECaqua (intermittent release), the results of the de Steger-Hartmann and Schmidt (1999) study were used. This is a reliable study (rated 2 according to the criteria set out by Klimisch, 1999) and gives the lowest results observed in the key information for any of the ecotoxicology endpoints. The study examined acute toxicity of the test substance to Daphnia over a 48 hour exposure period and was conducted in accordance with OECD guideline for testing number 202. The standard assessment factors given in the European Chemicals Agency guidance document (R.10: Characterisation of dose [concentration]-response for environment) have been used to predict the above PNEC values from the results.

The PNECstp has been derived based upon the Clarke (2010) study which provided a NOEC of 1000 mg/l . The standard assessment factors given in the European Chemicals Agency guidance document (R.10: Characterisation of dose [concentration]-response for environment) have been used to predict the PNEC values from the Clarke (2010) results.

PNECsediment and PNECsoil values have been estimated using the equilibrium partitioning method

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 LC50 (fish): >3.1 mg/l (Steger-Hartmann. T. and Wendt. B., 1998)

48 hour EC50 (Daphnia): <1 mg/l (Steger-Hartmann, T. and Schmidt, M., 1998)

72 hour EC50 (algae): >1 mg/l (Steger-Hartmann, T., 1999)

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

The lowest of these results is the 48 hour EC50 for Daphnia at < 1mg/L.

Classification and labelling and this meets the criteria under 67/548/EEC and EC Regulation 1272/2008 as follows:

67/548/EEC:

R50 and R53: Toxic 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 1, Acute: Category 1.