Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.42 µg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
4.2 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.04 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.42 µg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.031 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:
no exposure of soil expected

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

N-butyl-4,4 -bis(tert-butylperoxy)valerate has a Log Kow of 6.34 (OECD 117) and is not rapidly biodegradable.

Aquatic data are available from short-term toxicity tests at 3 trophic levels: the lowest available toxicity value has been obtained with algae corresponding to ErC50 of 421.5 µg/L. For the other trophic levels, crustacean and fish, no acute aquatic toxicity has been observed.

The only long-term aquatic toxicity data is available for algae corresponding to ErC10 of 160.5 µg/L.

Based on these data, the following aquatic hazard classification should be applied according to CLP criteria (Regulation (EC) No 1272/2008):

Acute aquatic hazard: category Acute 1, M-factor: 1;

Long-term aquatic hazard: category Chronic 2.