Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.33 µg/L
Assessment factor:
100

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.16 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:
0.33 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Acute classification

For fish, Daphnia and algae all endpoints are above the water solubility limit.

Chronic classification

1,1,3,3-Tetramethylbutyl peroxyneodecanoate is not readily biodegradable, and the measured log Kow is > 6.5. Chronic data available is 72 h ErC10 algae, 104.29 mg/L, loading and a 21d NOEL for Daphnia of 10 mg/L loading. When chronic data for less than 3 trophic levels are available the classification is assessed using both the existing chronic and acute data, and the most stringent outcome is chosen.

Based on chronic data: (72 h EL10 algae, 104.29 mg/L and 21 d NOEL Daphnia > 10 mg/L): No classification

Based on acute data (All endpoints > water solubility limit): No classification

Category chronic 4 evaluation - Substance is poorly water soluble, with no acute toxicity recorded up to the water solubility, is not rapidly degradable and the log Kow > 4. However the available chronic toxicity NOEC > water solubility and 1 mg/L , thus it does not fit into this category.

Most stringent outcome: None

Overall classification: None