Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

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

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
4.7 µg/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:
3.7 µg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Conclusion on classification

For the 3 trophic levels (fish, invertebrates (Daphnia) and algae), studies on the short-term toxicity of XDI and XDA have been evaluated (the long-term toxicity has not been investigated). The results as expressed in measured concentrations XDA have been converted to XDI concentrations for the purpose of CLP classification (Guidance on the application of the CLP criteria, 4.1.3.1.1.).

- 96h-LC50 for freshwater fish: 120.9 mg XDI/L

- 48h-EC50 for freshwater invertebrates: 13.4 mg XDI/L

- 72h-ErC50 for freshwater algae: 43.5 mg XDI/L

- 72h- ErC10 for freshwater algae: 29.8 mg XDI/L

As the lowest L(E)C50 value is 13.4 mg XDI/L and XDA, the main hydrolysis product, is not rapidly degradable, XDI should be classified as Harmful to aquatic life with long lasting effects (H412) in accordance with the CLP Regulation 1272/2008 (as amended by Regulation 286/2011) (Long-term aquatic hazard Chronic 3).

Please note that XDA has been registered with the same classification in its REACH lead registration dossier.

XDI should be classified as harmful to aquatic organisms, may cause long-term adverse effects in the aquatic environment (risk phrases R52/R53) according to Directive 67/548/EEC (DSD).