Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
3.2 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
46 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.32 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
1.15 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:
1.6 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

Tests with algae revealed the lowest values for aquatic organims. This value is not taken into account for calculation of PNECs, as the test substance is a complexing agent which can deprive micronutrients from the culture medium. Algae growth can be significantly reduced under standardized guideline conditions and may yield apparent results that are more or less severe than the true toxicity (see Guidance on Hazard to the Aquatic Environment Globally Harmonized System GHS Annex 9 A9.3.3.4, 2007). In conclusion PNEC calculation was based on the NOEC data from the species (daphnia) with concrete acute and chronic data.

Conclusion on classification

Based on aquatic toxicity test results obtained, EDDHMA-Fe is not classified and labelled according to Directive 67/548/EC (DSD) and Regulation 1272/2008/EC (CLP). Data for earthworms and birds confirm the low toxicity for also terrestrial organisms.

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