Registration Dossier

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:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.057 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:
0.055 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

For the test substance the base set data are available. A guideline study for short-term toxicity is available for freshwater fish. The critical acute effect concentration is a 96-h LC50 value of >1000 mg/L in zebrafish (Danio rerio) (CG, 1987).

A guideline short-term toxicity study is available for aquatic invertebrates. The critical effect concentration is a 24-h EC50 value of >1000 mg/L in Daphnia magna (RCC, 1987). A guideline growth inhibition study is available for freshwater algae. The critical effect concentrations are a 72-h ErC50 value of >100 mg/L and a 72 -h NOErC of 100 mg/L in Scenedesmus subspicatus (RCC, 1996). The ErC50 value of 100 mg/L is used for calculation of the aquatic PNECs. As no data on the toxicity towards freshwater or marine sediments or soil are available, the PNECs for sediments and soil are calculated with the Equilibrium PArtitioning Method (using EUSES v2.1). Long-term studies with fish and invertebrates are not available.

For the assessment of toxicity to microorganisms, a guideline respiration inhibition study with a mixed culture of bacteria is available. The critical effect concentration is a 3-h IC50 value of >100 mg/L (CG, 1987). This value is used for calculation of the PNEC-STP.

Conclusion on classification

Based on all available data for fish, aquatic invertebrates and algae, the test substance needs not to be classified according to Directive 67/548/EEC - Classification, Packaging and Labelling of Dangerous Substances or according to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (CLP))