Registration Dossier

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Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
0.004 mg/L

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:
5.63 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.563 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:
1.25 mg/kg soil dw
Assessment factor:
50
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Conclusion on classification

Additiv 104 can be considered insoluble in water, and in addition a substance made of multiple components of very high molecular weights and thus likely not bioavailable to create toxic effects. The hazard classification (R-51/53 or GHS 4 -11) comes from the most sensitive of 3 acute tests on freshwater organisms (Daphnia 48 -hr EC50/NOEC = 6.8/3.6 mg/L, respectively; when fish and algae showed that the acute endpoints were in excess of 10 mg/L). The aquatic tests were conducted as water accommodated fractions or WAFs, and owing to the complexity of the substance and inherent properties the analytical verifications have been based on indirect measurements.

Releases to the environment under normal conditions are minimal, and hence releases due to spills should be limited and easily contained for proper disposal. Al

hough the estimated concentrations have only limited relevance to the actual concentrations, a screening assessment indicates that the substance is less hazardous than what is assigned by GHS, and until better proof can be generated the conservative classification can be considered sufficient.