Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0 mg/L
Assessment factor:
1 000
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:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0 mg/L

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.195 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:
0.391 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1.66 mg/kg food
Assessment factor:
300

Additional information

Conclusion on classification

Key information for classification

Biodegradation: Not readily biodegradable (Pass level OECD301B test reached after 38 d with 61% (enhanced ready biodegradable)). Since the pass level of the OECD 301B test reached after a prolonged test duration up to 38 days, it can be considered that the substance will fully mineralize under environmental conditions within a short time period and thus persistency in the environment can be excluded.

Bioaccumulation: log Pow 7.04 (OECD 117, HPLC method)

Aquatic acute toxicity

- Fish (freshwater): LC50 (96 h) > 150 µg/L (Danio rerio, OECD 203, based on geometric mean measured concentrations)

- Aquatic invertebrates (freshwater): EC50 (48 h) = 76 µg/L (Daphnia magna, OECD 202, based on geometric mean measured concentrations)

- Algae (freshwater): ErC50 (72 h) = 160 µg/L (Desmodesmus subspicatus, OECD 201, based on geometric mean measured concentrations)

Aquatic chronic toxicity

- Algae (freshwater): ErC10 (72 h) = 95 µg/L (Desmodesmus subspicatus, OECD 201, based on geometric mean measured concentrations)

 

Conclusion on Classification

Based on the data above, the substance is not considered to be rapidly degradable in the environment and bioaccumulation cannot be excluded. Based on the acute and chronic data from aquatic organisms the substance needs to be classified and labelled as Acute Cat. 1 (H400) and Chronic Cat. 1 (H410) for environmental hazard according to the consolidated version of Regulation (EC) No 1272/2008 (dated: 01.01.2017) and further amendments (ATPs).

M-factor for acute aquatic toxicity: 10

M-factor for chronic aquatic toxicity: 10