Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.43 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
4.3 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.043 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.43 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
1.71 mg/kg soil dw
Assessment factor:
100

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Environmental fate and pathways

Biodegradation

Readily biodegradable: 85.2% within 28 d (OECD 301B)

Bioaccumulation

The potential for bioaccumulation is expected to be low.

Aquatic acute toxicity

Fish

LC50 (96h) > 0.43 mg/L for D. rerio (OECD 203)

Aquatic invertebrates

EC50 (48h) = 0.43 mg/L for Daphnia magna (OECD 202)

Algae

ErC50 (72h) > 4.4 mg/L for Desmodesmus subspicatus (OECD 201)

Aquatic chronic toxicity

Algae

NOErC = 0.91 mg/L for Desmodesmus subspicatus (OECD 201)

 

CLP

Based on the available data listed above, the most sensitive acute effect concentration was obtained for Daphnia magna, with an EC50 (48 h) of 0.43 mg/L (measured). Thus, the substance needs to be classified as environmental hazard Category Acute 1, according to the Regulation (EC) No 1272/2008 (CLP) and following amendments (ATPs).

M-factor for acute aquatic toxicity: 1

The NOErC (72 h) = 0.91 mg/L for algae is the only chronic aquatic effect concentration available. In addition, the substance is readily biodegradable and has a low potential for bioaccumulation. Thus, the substance is classified and labelled as long-term aquatic hazard Category Chronic 3, according to Regulation (EC) No. 1272/2008 (CLP) and following amendments (ATPs).

M-factor for chronic aquatic toxicity: not applicable.