Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
21.3 mg/L
Assessment factor:
10

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.017 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:
0.035 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.08 mg/kg food
Assessment factor:
900

Additional information

Conclusion on classification

The algae study is driving the classification for both acute (most sensitive endpoint) and chronic (only available NOEC) endpoints. Testing were done with river data (bulk approach) and a mitigation factor of 10 was used on river data to derive the correct classificaton of C16 -22 alkylamine.

Acute classification

The algae bulk approach ErC50 (river data) was 0.444 mg/L. This value was divided with a mitigation factor of 10 for classification purposes: 0.0444 mg/L.

Classification: Acute 1

M-factor: 10

Chronic classification

The substance is readily biodegradable

The substance has a BCF >500

The bulk approach NOEC (river data) was 0.159 mg/L. This value was divided with a mitigation factor of 10 for classification purposes: 0.0159 mg/L.

Classification: Chronic 1

M-factor: 10 (chronic data not available on all tropic levels and therefore acute M-factor is applied also on the long term hazard classification.