Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.002 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.015 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.166 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1.4 mg/kg food
Assessment factor:
300

Additional information

Short-term toxicity of TBHP to freshwater fish, invertebrates and algae has been determined experimentally. Algal growth inhibition proved to be the most sensitive indicator of toxicity and hence the 72h growth rate inhibition EC50 value for Selenastrum capricornutum was used as the critical indicator for calculation of PNEC values for aquatic organisms. The PNEC for STP microbes was calculated from an experimentally determined 30 -minute EC50 value for respiration inhibition in activated sludge. Sediment PNEC values were calculated from the freshwater organism EC50 data, based on equilibrium partitioning. The soil PNEC value was calculated from experimentally determined acute terrestrial organism (LC50) data.

Conclusion on classification

Based on the ErC50 result in the 72h freshwater algal growth inhibition test (1.5 mg/l) and the absence of degradation reported in tests of ready biodegradability, the classification of TBHP is concluded to be:

- under Directive 67/548/EEC criteria, R51/53

- under UN GHS criteria, hazardous to the aquatic environment, acute category 2 and chronic category 2.

- under Regulation 1272/2008 (CLP GHS) criteria, hazardous to the aquatic environment, chronic category 2.