Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.002 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:
0.004 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

Classification related key information

Biodegradation in water: screening tests: 85.2% (ThCO2) in 28 days (OECD 301B) (read-across)

Bioaccumulation: Low bioaccumulation potential expected (see IUCLID section 5.3.1 for details)

Acute toxicity:

- to fish: LC50 (96 h) = 0.37 mg/L for Brachydanio rerio (OECD 203)

- to aquatic invertebrates: EC50 (48 h) = 1.4 mg/L for Daphnia magna (OECD 202)

- to algae: ECr50 (72 h) = 6.3 mg/L, for Desmodesmus subspicatus (OECD 201) (read-across)

Chronic toxicity:

- to fish: not available

- to aquatic invertebrates: not available

- to algae: NOEC (72 h) = 0.91 mg/L for Desmodesmus subspicatus (OECD 201) (read-across)

 

Classification justification according to CLP

Based on the data above, Reaction products of oleoyl sarcosine with sodium hydroxide is considered rapidly biodegradable and has a low bioaccumulation potential. The acute aquatic toxicity EC50 value is < 1 mg/L for fish. Valid chronic toxicity data for fish and crustacea are not available. The NOEC for the algae Desmodesmus subspicatus is 0.91 mg/L, based on results from the structurally related substance (Z)-N-methyl-N-(1-oxo-9-octadecenyl) glycine (CAS 110-25-8). Reaction products of oleoyl sarcosine with sodium hydroxide needs to be classified as environmental hazard Acute Cat. 1 and Chronic Cat. 3 according to the Regulation (EC) No 1272/2008 (CLP) and the Regulation (EU) No 286/2011 (2nd ATP).

M-factor for acute aquatic toxicity: 1

M-factor for chronic aquatic toxicity: no factor assigned

  

Classification justification according to DSD

Based on the data above, Reaction products of oleoyl sarcosine with sodium hydroxide is considered to have low potential for bioaccumulation and is rapidly degradable. The acute aquatic toxicity EC50 value is < 1 mg/L for fish. Therefore, Reaction products of oleoyl sarcosine with sodium hydroxide needs to be classified as environmental hazard R50 according to the Directive 67/548/EEC.

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