Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.071 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.73 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
1.5 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
14.9 µg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.119 µg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.012 µg/kg sediment dw
Assessment factor:
500
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:
26.5 µg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Key information for classification

Degradation

Biodegradation: not readily biodegradable (1% degradation after 28 d (O2 consumption, OECD 301F)

Simulation tests: not rapidly biodegradable

 

Bioaccumulation

BCF (fish, Lepomis macrochirus): < 2 (OECD 305, lipid normalized steady state as well as growth and lipid corrected kinetic BCF)

 

Aquatic acute toxicity

For fish: 96 h, LC50 (Oncorhynchus mykiss, OECD 203): > 10 mg a.i./L (nominal)

For aquatic invertebrates: 48 h, EC50 (Daphnia magna, OECD 202): 0.1733 mg a.i./L (nominal)

For algae/aquatic plant: 72 h, ErC50 (Navicula pelliculosa, OECD 201): > 3.19 mg a.i./L (measured)

 

Aquatic chronic toxicity

For fish: 33 d, NOEC (Pimephales promelas, OECD 210): 2.5 mg a.i./L (nominal)

For aquatic invertebrates: 28 d, EC10 (Chironomus riparius, OECD 219): 0.00071 mg a.i./L

For algae/aquatic plant: 72 h, NOErC (Navicula pelliculosa, OECD 201): 0.285 mg a.i./L (measured)

 

Based on the data above, the acute aquatic toxicity EC50 (48 h) for Daphnia magna is < 1 mg/L. Thus, the substance needs to be classified as environmental hazard Acute Cat. 1 (H400) according to the consolidated version of Regulation (EC) No 1272/2008 (CLP) including all further amendments (ATPs).

M-factor for acute aquatic toxicity: 1

 

The test item is considered to be not rapidly degradable. Valid chronic toxicity data are available for fish, invertebrates and algae – the lowest EC10 (28 d) is 0.00071 mg/L for Chironomus riparius. Thus, the substance needs to be classified and labelled as long-term aquatic hazard Chronic Cat. 1 (H410) according to the consolidated version of Regulation (EC) No 1272/2008 (CLP) including all further amendments (ATPs).

M-factor for chronic aquatic toxicity: 100