Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.036 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
3.6 µg/L
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.042 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.004 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
5 µg/kg soil dw
Extrapolation method:
sensitivity distribution

Hazard for predators

Additional information

The PNEC for sediment is not possible to calculate at this time on the basis of real data, as insufficient data is available to assess these endpoints. As such, assessment utilising EUSES v2.1.1 has been carried out for this endpoint.

Conclusion on classification

The substance is classified on the basis of the results noted in the acute fish and Daphnia studies and is as follows:

 

Classified under the Dangerous Substances Directive (67/548/EEC) as:

R52/53 Harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

According to Regulation (EC) No 1272/2008 the substance is also classified as:

 

H412: Harmful to aquatic life with long lasting effects.

The environmental studies conducted on the substance have all been ranked reliability 1 according to the Klimish et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.

The results triggered classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008) as listed above.