Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.47 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
4.7 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:
0.047 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.005 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:
0.007 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
41.5 mg/kg food

Additional information

Aquatic toxicity (including STP)

Two reliable QSAR models were used to assess the aquatic toxicity of the registered substance to fish, aquatic invertebrates and algae: iSafeRat holistic approach v1.5 and ECOSAR v1.11 models. Both QSAR results are reliable as the registered substance falls within the applicability domain of the models and were used as key data points. Therefore, the E(L)C50 key values, used for chemical safety assessment, were determined as the geometric mean of predicted E(L)C50 values, corresponding to 4.7 mg/L for aquatic invertebrates, 9.3 mg/L for fish and 13.9 mg/L for algae. Finally, the registered substance is readily biodegradable and no inhibition effects of the activity of microorganisms was observed in the biodegradation study at 100 mg/L. Therefore, in accordance with column 2 of REACH Annex VIII, the activated sludge respiration inhibition test does not need to be conducted.

Sediment, terrestrial toxicity and hazard for predators

In the absence of any ecotoxicological data for sediment-dwelling/soil organisms, the PNEC sediment/soil were calculated using the equilibrium partitioning method (EPM).

Furthermore, no toxicity studies reporting the secondary poisoning effects on birds were available, therefore the lowest NOAEL value at 150 mg/kg bw/day obtained in the 2 -year carcinogenicity study (oral exposure) performed on the registered substance was used to derive the PNECoral.

Environmental fate and pathways

The registered substance is readily biodegradable (79% biodegradation after 28 days, within the 10 -day window) and therefore is not Persistent. In addition, the registered substance has a low potential for adsorption based on the low octanol water partition coefficient (log Kow = 2.1).

Conclusion on classification

No harmonised classification is available on the registered substance.

1 < lowest E(L)C50 value < 10 mg/L; readily biodegradable; log Kow lower than 4.0 (= 2.1).

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): The registered substance is not classified for the environment.