Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0 mg/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:
0.004 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0 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
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Environmental fate and pathways

Biodegradation: Readily biodegradable: 85.2% within 28 d (OECD 301B); read-across

Bioaccumuation: log D < 4 (used for ionisable substances instead of log Kow, SPARC v4.6)

Aquatic acute toxicity

Fish

LC50 (96 h) = 0.37 mg/L (nominal) for D. rerio (OECD 203); read-across

LC50 (96 h) > 0.43 mg/L (nominal) for D. rerio (OECD 203); read-across

Aquatic invertebrates

EC50 (48 h) = 0.01593 mg/L (TW mean, OECD 202, D. magna)

Algae

ErC50 (72 h) 6.3 mg/L (meas. initial) for Desmodesmus subspicatus (OECD 201); read-across

Aquatic chronic toxicity

Aquatic invertebrates

NOEC (21d) = 0.183 mg/L (TWA, OECD 211, D. magna); read-across

Algae

NOErC (72 h) = 0.91 mg/L (meas. initial) for Desmodesmus subspicatus (OECD 201); read-across

 

CLP

Based on the available data listed above, the most sensitive acute effect concentration was obtained for aquatic invertebrates, with an EC50 (48 h) = 0.01725 mg/L (TW mean). 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 NOEC (21d) = 0.183 mg/L (TWA) for aquatic invertebrates is the lowest of two (algae and daphnia) chronic aquatic effect concentration available. In addition, the substance is readily biodegradable and the log D < 4 (SPARC v4.6). Thus, the substance does not need to be classified for chronic toxicity based on acute toxicity data. However, the substance is classified and labelled as Chronic Category 3, according to Regulation (EC) No. 1272/2008 (CLP) and following amendments (ATPs) based on the long-term study with aquatic algae.

M-factor for chronic aquatic toxicity: not applicable.