Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
15 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.5 mg/kg sediment dw
Assessment factor:
1
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:
2.94 mg/kg soil dw
Assessment factor:
1
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

CLP: Chronic 3;  

GHS: Acute 3 and Chronic 3

 

EXPLANATIONS

1.    Acute classification

The existing acute data are as follows:

·        72 h EC50 algae = 36 mg/L; 48 h EC50 Daphnia = 73.1 mg/L, 96 hr Acute fish = 171 mg/L (algae used as worst case).

·     

CLP: As all effect values are above 1 mg/L,there is no acute classification for this substance.

GHS: As EC50 value is between 10 and 100 mg/L, Acute 3 is applicable in this case.

 

2.    Chronic classification

Di-tert butyl peroxide is not readily biodegradable, and the measured log Kow is 3.2. The chronic data available are as follows:

72 h ErC10 algae, 15 mg/L; 21 d NOEC Daphnia = 7.2 mg/L.

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 acute data (72 h EC50 algae = 36 mg/L): Chronic 3 

Based on chronic data: (72 h ErC10 algae, 7.2 mg/L): No classification

CLP and GHS: Most stringent outcome:Chronic 3