Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
100
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:
0.494 mg/kg sediment dw
Assessment factor:
10
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

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

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
10 mg/kg soil dw
Assessment factor:
100
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
90 300 g/kg food
Assessment factor:
90

Additional information

Conclusion on classification

The EC50for Daphnia and LC50for fish is >0.04 mg/L and so under Directive 67/548/EC 1,3:2,4-Bis-O-(3,4-dimethylbenzylidene)-D-glucitol should be classified as R50 (Very toxic to aquatic organisms). However the water solubility of 1,3:2,4-Bis-O-(3,4-dimethylbenzylidene)-D-glucitol is 0.0476 mg/L and so results from these studies have to be considered with caution. It is considered that due to the low water solubility of the substance, a study performed using higher test concentrations would show that the substance is not classified in line with Directive 67/548/EEC because of its very low water solubility. On this basis no classification is required.

Although the substance is classified as not readily biodegradable, the aquatic BCF is <150 and the chronic NOEC for Daphnia is above the water solubility limit thus R53 (May cause long-term adverse effects in the environment) is not considered to be required. The hazard symbol ā€˜Nā€™ (Dangerous for the environment) is also not required.