Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.008 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:
0.115 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.002 mg/kg soil dw
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 Hooftman RN and De Wolf JM, 2003b and 2004studies were used. These are reliable studies (rated 2 according to the criteria set out by Klimisch, 1999) and give 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 Stasinakis A et al 2001, study which provided a EC50 result of 11.5 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 Biemborn, 1999 results.

PNECsediment and PNECsoil values have been estimated using the equilibrium partitioning method, in the absence of measured physico-chemical data, based on physico-chemical properties determined by expert judgement.

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): > 4 mg/l (Hooftman RN and De Wolf JM 2003a)

48 hour EC50 (Daphnia): 0.843 mg/l (Hooftman RN and De Wolf JM, 2003b; Hooftman RN and De Wolf JM 2004)

72 hour EC50 (algae): 8 mg/l (Oldersma H et al 2003)

It should also be considered that the substance does not meet the definition of a readily biodegradable substance (Günzel P et al 1993).

The lowest of these results is the 48 hour EC50 for Daphnia (Hooftman RN and De Wolf JM, 2003b; Hooftman RN and De Wolf JM 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