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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1 mg/L

Marine water

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

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:
22.01 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
4.33 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Study reports have been available for consideration in respect of acute tests with fish, invertebrates, algae and micro-organism.

A PNECaquatic of 0.1 mg/l has been derived from 100 mg/l (the lowest short-term L/EC50 from each of three trophic levels (fish, Daphnia and algae)) by an assessment factor of 1000.

No measured data are currently available for marine organisms therefore the marine PNEC is derived from data obtained for freshwater species (L/EC50=100 mg/l), applying an assessment factor of 10000 to give PNECseawater = 0.01 mg/l.

The intermittent releases PNEC is derived from lowest value obtained for freshwater species (L/EC50 = 100 mg/l), applying an assessment factor of 100 to give PNECwater,intermittent = 1 mg/l.

The PNEC for waste-water treatment is 10 mg/l based on the IC50 of 1000 mg/l and an assessment factor of 100.

No toxicity data are currently available for sediment-dwelling organisms, therefore it is not possible to determine a PNECsed based on measured data. According to the Technical Guidance Document, PNECsed can be calculated by the equilibrium partitioning method . Hence, PNECsed (freshwater) = 22.01 mg/kg (based on Koc value of 2165 and PNECfresh-water of 0.1 mg/l) will be used for risk characterisation.

No toxicity data are currently available for marine sediment-dwelling organisms, therefore it is not possible to determine a PNEC sediment (marine water) based on measured data. According to the Technical Guidance Document, PNEC sediment (marine water) can be calculated by the equilibrium partitioning method. Hence, PNEC sediment (marine water) = 2.201 mg/kg (based on Koc value of 2165 and PNECmarine-water of 0.01 mg/l) will be used for risk characterisation.

No toxicity data are currently available, therefore it is not possible to determine a PNECsoil based on measured data. According to the Technical Guidance Document, PNECsoil can be calculated by the equilibrium partitioning method. Hence, PNECsoil = 4.33 mg/kg (based on Koc value of 2165, PNECfresh-water of 0.1 mg/l, vapour pressure of 1.19E-10 Pa at 25 °C, molecular weight of 495.3 g/mol and water solubility of 7 µg/l at 20 °C) will be used for risk characterisation.

Below table is the summary of the value of PNEC in each compartment.

Compartment

Value of PNEC

Freshwater

0.1 mg/l

STP micro-organisms

100 mg/l

Seawater

0.01 mg/l (extrapolation from freshwater)

intermittent release

1 mg/l (extrapolation from freshwater)

PNECsediment (freshwater)

22.01 mg/kg

PNECsediment (marine water)

2.201 mg/kg

PNECsoil

4.33 mg/kg

Conclusion on classification

From the available information, the lowest short-term L/EC50 from each of three trophic levels (fish, Daphnia and algae) was above 100 mg/l. In addition, although the substance is not readily biodegradable and poorly soluble in water, the logPow is 3.6 (<4). Therefore, it is not classified as per EU CLP (Regulation (EC) No 1272/2008) regulation.

However, as the threshold for logPow for classification in DSD is logPow = 3 the substance is classified as R53 according to DSD (Directive 67/548/EEC) for environmental properties.