Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.014 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.529 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:
1.05 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
83.3 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

TXIB is not acutely toxic at the limit of water solubility (saturation). However, a NOEC in a long-term study (Daphnia magna) was observed in the range of 0.1 to ≤ 1.0 mg/L. The experimental BCF is < 500. The substance achieved > 60% degradation based upon CO2 evolution in a ready biodegradtion study (OECD 301B) but failed to meet the 10-day window criterion. This is likley caused by the intial test substance being greater than the water solubility of the substance. However, as the substance exhibited greater than 70% biodegradation in the 28 day study the substance is considered to be rapidly biodegradable. Based upon the long-term NOEC in the range of 0.1 to ≤ 1.0 mg/L and the substance being considered rapidly biodegradable, the substance has been classified as Chronic Category 3 under the CLP.