Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.39 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.39 mg/L

Marine water

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

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:
4 685 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
468.5 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:
936.8 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

As a result of the hazard assessment it can be concluded that bis(4-tert-butylcyclohexyl) peroxydicarbonate meets the criteria for classification category "chronic 3". However, the substance cannot be considered to be a PBT/vBvP substance.

Conclusion on classification

Bis(4-tert-butylcyclohexyl) peroxydicarbonate is not readily biodegradable and does not hydrolyse. In the hydrolysis test it was not possible to evaluate whether the substance degrades in the test system or if it decomposes in the analytical equipment. Thus the log Kow of the substance could not be measured experimentally. Instead, the log Kow was estimated by QSAR using EPISuite (KOWWIN v1.68). The calculated log Kow for the substance is 8.34. The bioconcentration factor was also estimated by QSAR (BCFBAF v3.01/EPISuite), resulting in BCF = 2926 L/kg wwt.

Acute aquatic toxicity values are available for all three trophic levels. The lowest aquatic acute toxicity value is reported for algae (72-h ErC50 = 39 mg/L; geometric mean measured concentration). Chronic toxicity data are not available for this substance. As only acute toxicity values are available, the substance is assessed based on acute data, and classified accordingly.

A comparison of the lowest acute ErC50 of 39 mg/L with the environmental classification criteria shows that the substance qualifies for classification as category "chronic 3" based on acute (short-term) aquatic hazards: The EC50 is in the range of 10 to 100 mg/L. The substance is not rapidly biodegradable and has a potential for bioaccumulation based on its theoretically calculated BCF.