Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.056 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.756 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.006 mg/L
Assessment factor:
1 000
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:
1.971 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.197 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:
0.367 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

According to key study results of toxicity tests on invertebrates, fish, algae and microorganisms, acute harmfulness to aquatic organisms was observed with the most sensitive organism group (LC50 values = 75.6 mg/L - fish).

In a chronic study under semi-static conditions, the NOEC(21d) for Daphnia magna resulted in a value of 5.6 mg/L. Chronic results were available for 1-chlorobutane (daphnia and algae), hence an assessment factor of 100 was applied for the PNEC aqua (freshwater) derivation and an assessment factor of 1000 for the PNEC aqua (marine water) derivation on account of the unavailability of a chronic fish study.

The calculation of PNEC aqua (intermittent release) is based on the most sensitive acute study available (fish) with an LC50(96h) value of 75.6 mg/L. The PNEC sewage treatment plant is based on the low toxicity to microorganisms (EC50(3h)>1000 mg/L).

The substance will be predominantly found in the water and air compartment and no exposure of soil and sediments are expected.

The PNECs for sediment and soil were calculated according to the equilibrium partitioning method as described in the REACH Guidance Document R.10 (May 2008), using Equation R.10-2, R.10-3 and R.10-5 respectively.

An experimentally derived BCF value of <21 shows no significant bioaccumulation in Cyprinus carpio.

Conclusion on classification

The data is conclusive, but not sufficient for classification according to DSD (67/548/EEC) and CLP (1272/2008/EC).