Registration Dossier
Registration Dossier
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EC number: 208-534-8 | CAS number: 532-32-1
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.581 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 0.058 mg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.058 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
- PNEC marine water (intermittent releases):
- 0.006 µg/L
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 10 mg/L
- Assessment factor:
- 10
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 2.5 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.25 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:
- 0.159 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 300 mg/kg food
- Assessment factor:
- 30
Additional information
In absence of data on birds a calculation has been performed
PNECoral= Tox/AF
Tox= NOAELoral* conversion factor
The NOAEL oral is derived from a dietary study with 1% incorporated in food and converted to mg/kg bw. Therefore the original value of 10 g/kg food is taken as the value for Tox. The assessment factor is 30 (based on chronic data in rat, TGD part 2).
Conclusion on classification
All L/EC50's are >1 mg/L (lowest actual value is greater than 30.5 mg/L with algea, Migchielsen, 2010).
The freshwater algal growth inhibition test yields a EC10 (72h) of 6.5 mg/L (Migchielsen, 2010). Furthermore, the substance is readily biodegradable (Birch, 1989) and has a low potential for bioaccumulation.
Classification is not required for acute aquatic hazard if L/EC50's are > 1 mg/L; classification is not required for long-term aquatic hazard if EC10 > 1 mg/L .
Therefore in accordance with Regulation (EC) No. 286/2011 Table 4.1.0 the substance is not classified.
Justification for use of algal EC10: The reported NOEC for this study based upon time weighted average (TWA) concentrations do not accurately represent the intrinsic toxicity of the substance, which due to the issues with the lack of analytical detection of the test substance, the TWA concentrations that must be used resulted in a huge spacing factor between the LOEC and NOEC. EC10 better represent the potential toxicity of the substance as these are conservative estimates that biologically significant adverse effects are being demonstrated in the test.
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