Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.001 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.003 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
100
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:
0.016 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:
0.001 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Classification related key information

Biodegradation in water: screening test: Not readily biodegradable: 18% (ThCO2) in 28 days (OECD 301 B)

Log Kow: 2.9 (OECD 117)

BCF: 8.92 - 10.24 for Danio rerio (OECD 305 B)

Acute toxicity:

- to Fish: LC50 (96h) = 0.26 mg/L for Lepomis macrochirus (OECD 203)

- to Algae: ECr50 (72h) > 16.4 mg/L, for Scenedesmus subspicatus (OECD 201)

- to Crustacea: EC50 (48h) > 8.33 mg/L for Daphnia magna (OECD 202)

Chronic toxicity:

- to Fish: NOEC (35d) = 0.01 mg/L for Pimephales promelas (OECD 210)

- to Algae: NOEC (72h) = 4.4 mg/L for Scenedesmus subspicatus (OECD 201)

- to Crustacea: NOEC (21d) = 0.4 mg/L for Daphnia magna (EPA OPP 72-4)

 

Classification justification according to CLP

Based on the data above, the substance is considered not rapidly biodegradable. The acute aquatic toxicity LC50 is < 1 mg/L for Lepomis macrochirus. Valid chronic toxicity data are available for fish, algae and Daphnia – the lowest NOEC is < 0.1 mg/L for Pimephales promelas. Therefore, the substance needs to be classified and labelled as environmental hazard Acute Cat. 1 and Chronic Cat. 1 according to the Regulation (EC) No. 1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2ndATP).

M-factor for acute aquatic toxicity: 1

M-factor for chronic aquatic toxicity: 2

 

Classification justification according to DSD

Based on the data above, the substance is considered to have a low potential for accumulation but is not rapidly degradable. The acute aquatic toxicity LC50 is < 1 mg/L for fish. Therefore the substance has been classified and labelled as environmental hazard R50/R53 according to the Directive 67/548/EEC.