Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.21 mg/kg soil dw
Assessment factor:
1 000
Extrapolation method:
assessment factor

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

No short-term and long-term aquatic toxicity tests are available for EDTA-Mn(NH4)2 and read across was used to derive PNEC values for the aquatic compartment.

For sediment, no PNECs can be derived as not sufficient data is available. Based on the properties no adsorption of EDTA-Mn(NH4)2 onto the sediment and soil has to be expected, thus the assessment of this compartment will be covered by the aquatic assessment and can be based on the pore water concentration only.

Only one acute toxicity study with earthworms is available for EDTA-H4 (Edwards, 2009). The EC50 was determined at 156 mg/kg soil dry weight. This corresponds to 208 mg/kg soil dw EDTA-Mn(NH4)2 and is used to derive the PNEC soil.

Two acceptable studies with EDTA salts or complexes have been performed, examining different end-points (vegetative vigour and seedling emergence) in different plant species. In the 21d veg vigour study (Evangelou et al., 2006) a true NOEC could be established, while in the 14d seedling emergence test (Geebelen et al., 2002) no effect was observed at the highest tested dose. Recalculation of the NOEC from EDTA-Na2H2 to EDTA-Mn(NH4)2 will give a NOEC of 97.5 mg/kg soil dw.

The hazard assessment of EDTA-Mn(NH4)2 reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance. The substance is expected to have a low potential for adsorption based on its ionic structure under environmental relevant pH conditions and its low log Kow , the low log Kow also indicates that the substance will not be bioaccumulative. There are no further indications that the substance may be hazardous to the environment.

Conclusion on classification

All short-term L(E)C50 values are above 100 mg/l and all long-term values are (far) above 10 mg/l. Therefore EDTA-Mn(NH4)2 does not need to be classified as hazardous to the (aquatic) environment.