Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
4.37 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:
8.7 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Acute studies are available for fish, invertebrates and algae. The EL50 value for Acartia tonsa was 56 mg/L and the EL50 value for Skeletonema costatum was 24 mg/L. No effects were seen at 10 mg/L in a limit test for Cyprinodon variegatus.

Conclusion on classification

Under CLP legislation Distilled tall oil, maleated is assigned the classification Chronic Category 3.

Ecotoxicity results are available for fish, aquatic invertebrates and algae. The lowest EL50 value available for Distilled tall oil, maleated is 24 mg/L for algae, the LL50 for invertebrates is 56 mg/L. In a 96-hour acute toxicity test with fish no effects were observed at 10 mg/L WAF, the only test concentration. As these results are >1 mg/L no acute environmental classification is assigned to Distilled tall oil, maleated. A chronic environmental classification is assigned to Distilled tall oil, maleated as these results are >10 and ≤100 mg/L and Distilled tall oil, maleated is not readily biodegradable.

Under the DSD regulation Distilled tall oil, maleated is assigned a classification of R52 -53.

No acute classification is assigned as the lowest EL50 value is >1 mg/L. A chronic environmental classification is assigned to Distilled tall oil, maleated as the lowest EL50 value is >10 and ≤100 mg/L and Distilled tall oil, maleated is not readily biodegradable.

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