Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
2 520 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
2 210

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
252 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:
insufficient hazard data available (further information necessary)

Sediment (marine water)

Hazard assessment conclusion:
insufficient hazard data available (further information necessary)

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
2.2 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Modeled aquatic and earthworm data document that isomaltulose is not toxic to aquatic or terrrestrial organisms. No adequate PNECs can be calculated because the modeled data suggest no toxicity at concentrations exceeding 1500000 mg/L for aquatic organisms and 2253 mg/kg for earthworms. Isomaltulose greens is not toxic.

Conclusion on classification

Based on the lack of toxicity to aquatic or terrestrial organisms, isomaltulose greens is not classified.