Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
10.39 mg/kg sediment dw

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.04 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:
2.06 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
1.11 mg/kg food
Assessment factor:
1 800

Additional information

Conclusion on classification

The substance Isosorbide dioctanoate is readily biodegradable. Since its log Kow is > 4, the substance is considered as bioaccumulable.

On the basis of the results obtained in the acute aquatic toxicity tests performed on the three trophic levels (fish, invertebrate and algae) and in the long-term reproduction toxicity test on Daphnids, it appears that the substance Isosorbide dioctanoate shows no adverse effects to the aquatic organisms when exposed at its solubility limit in the test media.

Taking into account the above properties and the criteria as defined in the Regulation N.1272/2008 on the classification and labelling, the substance Isosorbide dioctanoate is not classified for the environment.