Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.045 mg/L
Assessment factor:
100
PNEC freshwater (intermittent releases):
0.53 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.024 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:
0.012 mg/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

According to 67/548 EC and the results mentioned hereafter, 11 -aminoundecanoic acid is classified as R52.

  • Short term Toxicity to Fish: LC50-96h > 833mg/L (OECD 203) (val 2b) Based on the results of this study, 11 -aminoundecanoic acid is not classified as harmful to fish in accordance with the Directive 67/548/EC.
  • Short term toxicity to aquatic invertebrates: EC50-48h > 350mg/L (OECD 202) (val 1a). Based on the results of this study, 11- aminoundecanoic acid is not classified as harmful to aquatic invertebrates in accordance with the Directive 67/548/EC.
  • Tocicity to aquatic algae: EC50 -72h=53 mg/L (growth rate); NOEC-72h = 4.5(growth rate); EC10 -72h = 10mg/L (growth rate) (val 1a) according to EU regulation (Dir 67/548/EEC), in the tested conditions11-aminoundecanoic acid is considered as harmful to algae in accordance with the Directive 67/548/EC.
  • Toxicity to aquatic micro-organisms: EC50-16h=1.5mg/L (P. putida ISO/DIS 10712) (val 2b). Based on the results of this study, 11 -aminoundecanoic acid shows toxicity to Pseudomonas putida.

 

According to CLP, these results are conclusive but not sufficient for classification.