Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.03 mg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.54 mg/L

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
430 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.017 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:
0.031 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Acute toxicity:

Invertebrates are the most sensitive species to the toxic effects of 4-OH TEMPO with an acute EC50 of 54 mg/L. Based on the results obtained in the aquatic toxicity studies, 4-OH TEMPO is not classified with respect to acute toxicity to the environment according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP/GHS).

Chronic toxicity:

Invertebrates are the most sensitive species to the toxic effects of 4-OH TEMPO with an acute EC50 of 54 mg/L and a NOEC of 1.5 mg/L derived from a daphnia reproduction study. Classification is based on the chronic daphnia study. Based on these results, the substance does not require classification for environmental chronic toxicity according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP/GHS).