Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.12 µg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.002 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:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The 72 hr Yield EC50 of 1.2 mg/L from the GLP, O.E.C.D. Testing Guideline 201, "Alga, Growth Inhibiton Test", study was the lowest EC50/LC50 value from the three acute aquatic toxicity studies. Therefore, this value was used to derive the PNECs for freshwater and marine environments and the intermittent release. Because little or no release to the aquatic and terrestrial environments is anticipated an oral PNEC is not justified. Due to relatively rapid photodegradation in the atmosphere and lack of inhalation health hazard a PNEC Air is not supported.

Conclusion on classification

Based on the acute algal 72 hr EC50 value of 1.2 mg/L for 2,3 -epoxypropyl neodecanoate and the substance is not readily biodegradable, CLP/GHS Chronic Category 2, H411, "Toxic to aquatic life with long lasting effects.