Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.87 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
8.7 µg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.002 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:
0.003 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
10 mg/kg food
Assessment factor:
300

Additional information

PNEC aqua: The PNEC aqua was derived on the basis of the lowest acute toxicity test (LC50 or EC50) for all 3 trophic levels (fish, daphnia , algae) and applying an assessment factor of 1000. The PNEC aqua is based on the test for acute toxicity in fish : PNEC aqua = 0.87 mg/l/ 1000 = 0.00087 mg/l

PNEC marine aqua: The PNEC marine aqua was derived on the basis of the lowest acute toxicity test (LC50 or EC50) for all 3 trophic levels (fish, daphnia , algae) and applying an assessment factor of 10,000. The PNEC aqua base on the test for acute toxicity in fish : PNEC aqua = 0.87 mg/l/ 10000 = 0.000087 mg/l

PNEC aqua intermittent: The PNEC aqua intermittent was derived on the basis of the lowest acute toxicity test (LC50 or EC50) for all 3 trophic levels (fish, daphnia , algae) and applying an assessment factor of 100. The PNEC aqua intermittent base on the test for acute toxicity in fish : PNEC aqua = 0.87 mg/l/ 100 = 0.0087 mg/l

PNEC STP: The PNEC STP was derived on the basis of the acute toxicity test for aquatic microorganisms (OECD 209) and applying an assessment factor of 100. PNEC STP = EC50: 625 mg/l/ 100 = 6.25 mg/l

PNEC sediment

The PNEC sediment was derived on the basis of the equilibrium partitioning method ( REACH: Technical guidance document for preparing the chemical safety assessment: R10.6.3).

PNEC marine sediment

The PNEC marine sediment was derived on the basis of the equilibrium partitioning method ( REACH: Technical guidance document for preparing the chemical safety assessment: R10.6.3).

PNEC soil

The PNEC soil was derived on the basis of the equilibrium partitioning method ( REACH: Technical guidance document for preparing the chemical safety assessment: R10.7.1).

PNEC oral: The NOAEL derived from a 28 day combined oral reproductive study (rat) is 300 mg/kg bw/d, a conversion factor (kg bw/kg food) and an assessement factor of 300 was applied.

Conclusion on classification

The substance is readily biodegradable and has a logPow of 4.35.

Ecotoxicological classification is required since the minimum aquatic toxicity (acute) is in the range of 0.1 to 1 mg/l and as logPow>4 – thus the substance should be classified with Acute 1, m-acute=1 and Chronic 1, m-chronic=1.