Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.04 µg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.02 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.104 µg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.02 mg/L

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.11 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:
0.31 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
133 g/kg food

Additional information

The PNEC for waste-water treatment is 10 mg/l based on the NOEC of 100 mg/l and an assessment factor of 10.

Conclusion on classification

Dicyclohexyl phthalate has been investigated for acute aquatic toxicity in fish (result LC50 (96h, Oryzias latipes) > 2 mg/l), in daphnia (result EC50 (48h daphnia magna) > 2 mg/l) and algae (result EC50 (72h, Pseudokirchnerella subcapitata) > 2 mg/l), the substance is readly biodegradable and has a BCF of 85 therefore it can not be classified for acute aquatic toxicity.

One long-term toxicity to aquatic invertebrates (Daphnia magna) showed a NOEC (21d)= 0.181 mg/L. Additionally a NOEC (64d) of 66.6 μg/l was identified in the fish sexual development study. Some other effects were observed in lower concentrations but should not be accounted for classification purposes.

Considering the above, a classification of the substance as an Aquatic Chronic 2 (H411), is proposed.