Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
32 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
94 µg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
22.8 µg/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:
26.9 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

As a result of the hazard assessment it can be concluded that bis(2-ethylhexyl)peroxydicarbonate does not meet the criteria for classification as dangerous or to be considered as PBT/vPvB.

Conclusion on classification

Bis(2-ethylhexyl)peroxydicarbonate hydrolyses instantly (t½ < 1 h at 5 °C) and is readily biodegradable (97 % within 28 days, however failing the 10-day-window criterion). Due to the rapid hydrolysis the classification is based on the intrinsic substance properties of the main degradation product 2-ethylhexan-1-ol. 2-ethylhexan-1-ol itself is also readily biodegradable and has no potential for bioaccumulation (log Kow < 3).

Acute toxicity values are available for all three trophic levels. The lowest aquatic acute toxicity value is reported for Daphnia magna. Bis(2-ethylhexyl) peroxydicarbonate was tested in 25 % isododecane. Test substance concentrations were verified via the quantification of the degradation product 2-ethylhexan-1-ol. The EC50 was determined to be 9.4 mg/L (measured concentration of 2-ethylhexan-1-ol).

Chronic toxicity data are available for algae and daphnia. Again daphnia were more sensitive than algae. The 21-day NOEC for reproduction was determined to be 1.6 mg/L (actual measured concentration of 2-ethylhexan-1-ol).

As chronic toxicity values are available for only two trophic levels, the substance is assessed based on both acute and chronic toxicity data and classified according to the most stringent outcome.

A comparison of the lowest acute toxicity value (EC50 = 9.4 mg/L) to the environmental classification criteria shows that the substance does not qualify for the classification categories for acute (short-term) aquatic hazards: As the EC50 is not ≤ 1 mg/L classification as category "Acute 1" is not warranted. In addition, the EC50 is in the range of > 1 to ≤ 10 mg/L, however, since 2-ethylhexan-1-ol is rapidly biodegradable and has no potential for bioaccumulation, the substance does also not need to be classified in category "Chronic 2".

A comparison of the most sensitive chronic toxicity value with the classification categories for rapidly biodegradable substances does not result in a classification of the substance because the 21-day NOEC for reproduction of daphnia magna is above the classification criteria for category "Chronic 3" of > 0.1 to ≤ 1 mg/L.

Based on the data presented above classification for environmental hazards is not warranted.