Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1 µg/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:
0.1 µg/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:
0.45 µg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.45 µg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

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) > 3 mg/L, for Pseudokirchneriella subcapitata (OECD 201)

- to aquatic invertebrates: EC50 (48h) = 2.24 mg/L for Chironomus riparius (OECD 235)

- to aquatic plants: IC50 (7 d) > 4.07 for Lemna gibba (OECD 221)

Chronic toxicity:

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

- to Algae: NOEC (72h) = 0.375 mg/L for Scenedesmus subspicatus (OECD 201)

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

- to aquatic plants: NOEC (7 d) = 0.039 mg/L for Lemna gibba (OECD 221)

 

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 consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs).

M-factor for acute aquatic toxicity: 1

M-factor for chronic aquatic toxicity: 10