Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.2 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
1.2 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.12 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.69 µg/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:
0.68 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The new study performed according to OECD guidelines 211 leads to an increase of the PNEC for aquatic freshwater compartment by a factor of 10. It impacts in the same manner the PNECs for the sediment and soil compartments.

Conclusion on classification

Based on acute toxicity tests on fish, invertebrates and algae, 4 - TBC appears to be very toxic to the aquatic organisms; with reliable L/EC50 values ranging from 0.1 to 1 mg/L. In addition, the results of ready biodegradation study shows that 4 - TBC is not readily biodegradable. As a consequence, 4 - TBC is classified regarding its environmental impacts, N; R50/53 under the criteria of Directive 67/548/EEC and Aquatic Acute Cat. 1 (H400) with M factor = 1 under Regulation (EC) No 1272/2008.

A chronic Daphnia magna study is also available which resulted in a NOEC of 0.135 mg/l. Based on this study the substance is classified in Aquatic Chronic Category 2 (H411) under Regulation No. 1272/2008.