Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.007 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.014 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.001 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.032 mg/kg sediment dw

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.025 mg/kg soil dw

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 Roode and de Haan (2004) 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 chronic toxicity of the test substance to Daphnia over a 21 day exposure period and was conducted in accordance with OECD guideline for testing number 211. 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 Oldersma et al, 2004 results.

The PNECstp has been derived based upon the Biemborn, 1999, study which provided a EC50 result of >1000 mg/l. As it is not possible to derive a PNEC value from a greater than value, expert judgement has been applied and an EC50 value of 1000 mg/l is therefore considered the worst case for toxicity to microorganisms. 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 Biemborn, 1999 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): >11.4mg/l (Steger-Hartmann. T, Wendt. B 1998)

48 hour EC50 (Daphnia): >1.4 mg/l (Steger-Hartmann. T, Schmidt. M 1998)

21 d NOEC (Daphnia): 0.098 mg/l (de Roode D.F. and de Haan H.P.M. 2004)

72 hour ErC50 (algae): >0.646 mg/l (NOEC ≥ 0.646 mg/L) (Odersma. H, Hanstveir. A.O, de Haan. H.P.M 2004)

It should also be considered that the substance does not meet the definition of a readily biodegradable substance (Beimborn, 2000).

The lowest of these results is the 21 day NOEC for Daphnia (de Roode and de Haan 2004), and this end-point has been used for 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: Very toxic to aquatic organisms and May cause long-term adverse effects to the aquatic environment.

EC Regulation 1272/2008:

Hazardous to the aquatic environment, Acute: Category 1 and Chronic: Category 1