Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
1 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

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

Sediment (marine water)

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

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.036 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Additional information

Short-term toxicity tests are available for all three trophic levels (fish, invertebrates and algae).

Fish

A GLP-compliant OECD guideline 203 study is available for EEA-NH4 (Kurume Laboratory, 2006b). In this semi-static limit test with analytical monitoring a 96-h LC50 value of >100 mg/L (nominal concentration) was observed in medaka (Oryzias latipes).

Invertebrates

A GLP-compliant OECD guideline 202 study is available for EEA-NH4 (Kurume Laboratory, 2006c). In this static limit test with analytical monitoring a 48-h EC50 value of >100 mg/L (nominal concentration) was observed inDaphnia magna.

Algae

A GLP-compliant OECD guideline 201 study is available for EEA-NH4 (Kurume Laboratory, 2006d). In a limit test with analytical monitoring a 72-h EC50 value of >100 mg/L and a 72-h NOErC of <100 mg/L (nominal concentrations) were observed inPseudokirchneriella subcapitata.

 

Furthermore, a GLP-compliant OECD guideline 209 study is available for EEA-NH4 (NOTOX, 2008). In this study with activated sludge from a municipal sewage treatment plant a 3-h EC50 value of >100 mg/L was determined.

Conclusion on classification

The L(E)C50 values were >100 mg/L for the three trophic levels tested (fish, invertebrates and algae). Therefore the substance does not need to be classified according to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.