Registration Dossier

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):
0.001 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0 mg/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:
2.5 mg/kg sediment dw
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.25 mg/kg sediment dw
Assessment factor:
1 000
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 mg/kg soil dw
Assessment factor:
50
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

Hydrolysis: hydrolytically stable at pH 5, 7 and 9 (OECD 111)

Simulation tests: not rapidly biodegradable

 

Bioaccumulation

Log Kow: -1.36 at 23 °C (OECD 107, shake-flask method)

 

Aquatic acute toxicity (freshwater)

For fish: 96 h, LC50 (Oncorhynchus mykiss, OECD 203): > 100 mg test item/L (nominal)

For aquatic invertebrates: 48 h, EC50 (Daphnia magna, OECD 202): > 100 mg test item/L (nominal)

For algae: 72 h, ErC50 (Pseudokirchneriella subcapitata, OECD 201): 29.8 mg a.i./L (mean measured)

For aquatic plants: 7 d, EC50 (Lemna gibba, EPA OPPS 850.4400): 0.110 mg a.i./L (mean measured)

 

Aquatic acute toxicity (marine water)

For fish: 96 h, LC50 (Cyprinodon variegatus, OECD 203): > 100 mg a.i./L (nominal)

For aquatic invertebrates: 48 h, EC50 (Americamysis bahia, EPA OPP 72-3): 1.1 mg a.i./L (nominal)

For algae/aquatic plant: 72 h, ErC50 (Skeletonema costatum, OECD 201): 15.7 mg a.i./L (mean measured)

 

Aquatic chronic toxicity (freshwater)

For fish: 21 d, NOEC (Pimephales promelas, OECD 210): 0.58 mg a.i./L (measured)

For aquatic invertebrates: 21 d, NOEC (Daphnia magna, OECD 211): 12.8 mg a.i./L (measured)

For algae: 72 h, NOErC (Pseudokirchneriella subcapitata, OECD 201): 6.4 mg a.i./L (mean measured)

For aquatic plants: 7 d, NOEC (Lemna gibba, OPPTS 850.4400): 0.00957 mg a.i./L (mean measured)

Aquatic chronic toxicity (marine water)

For fish: no data available

For aquatic invertebrates: no data available

For algae/aquatic plant: 72 h, NOErC (Skeletonema costatum, OECD 201): 6.4 mg a.i./L (mean measured)

 

Based on the data above the substance is not rapidly degradable. Aquatic plants turned out to be the most sensitive species (EC50 (7 d) 0.110 mg a.i./L; NOEC (7 d) 0.00957 mg a.i./L). This study investigates both, the acute and chronic effects. Thus, the test item has to be classified as Acute Cat. 1 (H400) and Chronic Cat. 1 (H410) according to Regulation (EC) No. 1272/2008 (CLP) and following amendments (ATPs). In conclusion the substance is labelled as Chronic Cat. 1 (H410).

M-factor for acute aquatic toxicity: 1

M-factor for chronic aquatic toxicity: 10