Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.27 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.55 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.027 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.88 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:
3.59 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Further investigations on reproduction toxicity of 4,4 -sulphonyldiphenol on fish are ongoing. Therefore the derived PNEC for the water compartment should be considered as not conclusive.

Conclusion on classification

Acute data from fish and algae indicate L(E)C50 values of 4,4 -sulphonyldiphenol greater than 100 mg/L. The EC50 for daphnia is 55 mg/L. Long-term studies in both invertebrates and fish reveal a NOECs clearly above 1 mg/L. Furthermore, the NOEC derived from the algae study also is clearly above 1 mg/L as well. The substance is not readily biodegradable and has no potential for bioaccumulation.

Summarizing the data available for 4,4 -sulphonyldiphenol and taking into account the provisions laid down in Council Directive 67/548/EEC and CLP (GHS), the substance does not have to be classified for environmental hazards.