Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.022 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.49 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.002 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.008 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:
0.003 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
133.3 mg/kg food
Assessment factor:
90

Additional information

Conclusion on classification

Classification justification according to CLP:

Based on the available data, Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and stearic acid is considered to be rapidly degradable and has low potential for bioaccumulation. The short-term aquatic toxicity L(E)C50 are above 1 mg/L for fish, invertebrates and algae. Valid chronic toxicity data are available for invertebrates and algae – the lowest NOEC is 0.218 mg/L (thus in the rage of > 0.1 to < 1 mg/L) for aquatic invertebrates. Thus, the substance needs to be classified and labeled as environmental hazard Chronic Cat. 3 according to the Regulation (EC) No.1272/2008 (CLP) and the Regulation (EU) No. 286/2011 (2nd ATP).

Classification justification according to DSD:

Based on the available data, Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and stearic acid is considered to be rapidly degradable and has a low potential for bioaccumulation. The short-term aquatic toxicity L(E)C50 values are above 1 mg/L for fish, invertebrates and algae. Thus, the substance does not need to be classified and labeled as environmental hazard according to Directive 67/548/EEC.