Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.001 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:
0.25 mg/kg soil dw
Assessment factor:
10
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

Conclusion on Classification

Biodegradation: 37% after 28 d (ISO 14593)

Bioaccumulation: no potential for bioaccumulation

 

Aquatic acute toxicity

Fish: 96 h, LC50 (Oncorhynchus mykiss): 0.355 mg/L (nominal; OECD 203)

Aquatic invertebrates: 48 h, EC50 (Daphnia magna): 0.59 mg/L (nominal; OECD 202)

Aquatic algae: 72 h, EC50 (Desmodesmus subspicatus): 0.0087 mg/L (measured, geometric mean; OECD 201)

 

Aquatic chronic toxicity

Fish: 28 d, chronic value (fish): 0.012 - 0.039 mg/L (ECOSAR v1.00)

Aquatic invertebrates: 21 d, NOEC (Daphnia magna): 0.1 mg/L (meas. TWA; OECD 211)

Aquatic algae: 72 h, NOEC (Desmodesmus subspicatus): 0.0044 mg/L (measured, geometric mean; OECD 201)

 

Classification according to CLP

Based on the data above, Atmer 163 needs to be classified and labeled as environmental hazard Acute Cat. 1 according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP) based on the EC50 (72 h) of 0.0087 mg/L for Desmodesmus subspicatus.
Atmer 163 is not considered to be rapidly degradable. Valid chronic data are available for aquatic invertebrates and algae. The lowest NOEC is 0.0044 mg/L for Desmodesmus subspicatus. Thus, the test substance needs to be classified and labeled as long-term aquatic Chronic Cat. 1 according to the 2ndATP of Regulation (EC) No. 1272/2008 (CLP).

M-factor for acute aquatic toxicity: 100
M-factor for chronic aquatic toxicity: 10

 

Classification according to DSD

Based on the data above, Atmer 163 is not considered to be rapidly degradable. The acute aquatic toxicity EC50 is 0.0087 mg/L (measured, geometric mean) for Desmodesmus subspicatus. Atmer 163 needs to be classified and labeled as environmental hazard R50/53 according to the Directive 67/548/EEC.