Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
1.8 µg/L
Assessment factor:
50
PNEC freshwater (intermittent releases):
4.2 µg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
180 ng/L
Assessment factor:
500

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
2 mg/L
Assessment factor:
10

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
1.72 mg/kg sediment dw
Assessment factor:
50
Extrapolation method:
assessment factor

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.172 mg/kg sediment dw
Assessment factor:
1
Extrapolation method:
assessment factor

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
0.011 mg/kg food

Additional information

Conclusion on classification

Classification according to DSD (Dangerous Substance Directive 67/548/)

Etherdiamines will be classified R50/53 this is based on the following results;

Although Etherdiamine was found to degrade in a prolonged biodegradation test they could not be proved to be readily biodegradable therefore they are classified R 53.

In a test performed in river water the EC50 for algea was found to be 0.42 mg/L, taking into consideration the mitigation factor of 10 which is to be used when using river water test for classification the EC50 will be 0.042 mg/L. The etherdiamine should therefore be classified R50

Classification according to CLP (Classification, Labeling & Packaging Directive 1272/2008/EC)

Based on the corrected EC50 value for algea of 0.042 mg/L the following classification i relevant:

Acute (short-term) aquatic hazard Acute Category 1

The corresponding M-factor is 10 based on the EC50 of 0.042 mg/L (72h algae river water test of 0.42 mg/L corrected with factor of 10)

When chronic toxicity data are available these should be used for classification for chronic aquatic hazard.

Based on the not readily biodgradable property and corrected NOEC value for daphnia of 0.009 mg/L the following chronic classification is relevant:

Chronic(Long-term) aquatic hazard Chronic Category 1

The corresponding M-factor is 10 based on the NOEC of 0.009 mg/L (21d NOEC daphnia river water test of 0.09 mg/L corrected with factor of 10)

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