Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.2 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.29 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.02 mg/L
Assessment factor:
500
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
2 870 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
287 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:
573 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

The substance does not show any effects in acute tests on algae, aquatic invertebrates and fish although the tested concentrations were well above the limit of water solubility and sometimes even a solubilizer was used which enhances the bioavailability of the substance. Nevertheless, as the substance is poorly soluble chronic tests are supposed to give more robust results and to clarifiy whether CLP classification chronic Cat.4 might be necessary. Therefore, a chronic reprodction test on Daphnia magna was performed. Also in this test no effects were found. A chronic test on fish was not performed due to animal welfare reasons. Although, only two of the three trophic levels have chronic data available it can be assumed that the substance is neither acutely nor chronically toxic to aquatic organisms.

Regarding bioaccumulation and biodegradation the data also suggest that the substance does not need to be classified CLP Chronic Cat. 4. The BCF estimation suggests a low potential for bioaccumulation due to metabolism. Furthermore, the high logPow indicates a decreased bioavailability. An enhanced biodegradation test over 60 days shows, that the substance continuously degrades.

Overall it can be assumed that the substance does not meet the criteria laid down in Council Directive 67/548/EEC and CLP (GHS) 1272/2008. Hence, the substance does not have to be classified with respect to acute and chronic ecotoxicity. Subsequently, no exposure assessment for the environment is performed.