Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
21.8 µg/L
Assessment factor:
50
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
82 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
2.18 µg/L
Assessment factor:
500
Extrapolation method:
assessment factor
PNEC marine water (intermittent releases):
8.2 µg/L

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
800 mg/L
Assessment factor:
1
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
17.3 µg/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:
21.74 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Environmental classification justification

Harmonised classification regarding environmental hazards

Aquatic compartment

For n-butylamine, a harmonised classification is available in Regulation (EC) 1272/2008 (CLP) Annex VI. The substance is not classified for environmental hazards.

Self-classification according to REGULATION (EC) No. 1272/2008 (CLP)

Aquatic compartment

According to REGULATION (EC) No. 1272/2008 (CLP), the substance is not to be classified as acutely hazardous to the aquatic environment since the lowest LC/EC50 is > 1 mg/L. The substance is also not to be classified as chronically hazardous as it is rapidly degradable and the available effect values for chronic effects on daphnids and algae are > 1 mg/L.

Atmospheric compartment

The test substance is not listed in Annex 1 of Regulation (EC) 2037/2000 on substances that deplete the ozone layer.

The test substance does not belong to the green house gases listed in P Forster, PV Pamaswamy et al. Changes in Atmospheric Constituents and Radiative Forcing. In: Climate Change 2007: The Physical Basis. Contribution of Working Goup 1 to the Fourthe Assessment Report of the Intergovernmental Panel on climate Change.

Self-classification according to UN-GHS ST/SG/AC.10/30 /Rev.7 (2017)

Because of E(L)C50-Values between 1 and 10 mg/L (Aquatic invertebrates EC50 (48 h) = 8.2 mg/L), the following acute toxicity classification applies:

o       Aquatic Acute 2

o       H401: Toxic to aquatic life.

For chronic aquatic toxicity, no classification is applicable (see EU-GHS (CLP) above for details).