Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
124 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.13 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:
0.25 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

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

Additional information

Environmental fate and pathways

Further investigation is ongoing on this difficult substance in order to determine whether instability or analytical issues account for the rapid loss observed under ecotoxicological test conditions.

The substance is considered to be readily biodegradable, with a log Koc at 3.83 (Koc = 6 720) and an estimated bioconcentration factor (BCF) at 319.3 L/kg.

Aquatic toxicity

Based on the analytical problems observed in the experimental ecotoxicological studies, a weight of evidence approach using both in vivo and QSAR estimations has been used to assess the aquatic toxicity of the substance. Further investigation is ongoing on this difficult substance in order to determine whether instability or analytical issues account for the rapid loss observed under ecotoxicological test conditions.

To obtain reliable endpoint values, geometric means between the experimental results (based on initial measured concentrations) and the QSAR estimations (ECOSAR v1.11 QSAR model available from the U.S. EPA) were determined for three trophic levels: Algae, Invertebrates and Fish.

Among all data available, fish seems to be the most sensitive species in acute exposure with an estimated 96h-LC50 at 1.87 mg/L.

No valid chronic studies are available. The choice to perform long-term studies will be defined after further investigation on this difficult substance.

Terrestrial toxicity

Based on a conservative estimation from Chesar, the chemical safety assessment of the substance indicates no need to investigate terrestrial testing. For this reason, terrestrial toxicity studies are scientifically unjustified.

Conclusion on classification

1 mg/L < E(L)C50< 10 mg/L; readily biodegradable; log Kow = 4.3 but estimated BCF = 319.3 L/kg.

Classification according to the Annex VI of the Directive 67/548/EEC: The substance is classified as N, R51/53 for the environment.

Classification according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP): According to the 2nd ATP, the substance is not classified for the environment.