Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
1.15 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.023 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:
0.099 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The O.E.C.D. 201, GLP Algal Inhibition test with an EC50 of 11.5 mg/L was the lowest EC/LC50 value for the three organisma evaluated (algae, Daphnia, Trout). Therefore, this EC50 value of 11.5 mg/L is most appropriate Classification and Labeling purposes.

Conclusion on classification

Based on EU Directive 67/548/EEC and an EC50 of 11.5 mg/L the test substance, 4,4'-Isopropylidenedicyclohexanol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, requires R52 and R53, Harmful to aquatic organisms, and may cause long-term adverse effects in the aquatic environment.

Under the EU CLP, Chronic Category 3, "Harmful to aquatic life with long lasting effects" is required.