Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.007 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.075 mg/L

Marine water

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

STP

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

Sediment (freshwater)

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

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.04 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:
0.075 mg/kg soil dw
Extrapolation method:
sensitivity distribution

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

The test substance has to be classified as "Aquatic Chronic 2" with Hazard statement 411 (H411; Toxic to aquatic life with long lasting effects) and Precautionary statements P273 (Avoid release to the environment), P391 (Collect spillage) and P501 (Dispose of contents/container in accordance with local/regional/national/international regulations). The corresponding label is pictogram GHS 09 ("fish and tree"). The available acute toxicity data to fish leads to this classification and labelling according to Regulation (EC) No 1272/2008. This well-documented study was conducted under GLP compliance and in accordance to OECD guideline 203 and EU Method C.1 with rainbow trout (Oncorhynchus mykiss) and resulted in an LC50 of 7.5 mg/L (Wetton and Mullee, 2001). This classification and labelling is reinforced by the fact that the test substance is not readily biodegradable (experimentally determined (Mead, 2001) and QSAR based predicted by Chemservice S.A., 2011) and since the substance has a good water solubility (Chemservice S.A., 2011), no doubts can be found on these experimental procedures. Furthermore, a supporting study for fish is also available (Rudolf, 2004). An acute toxicity study is also available for aquatic invertebrates, which was conducted under GLP compliance and in accordance to OECD guideline 202 and EU Method C.2 with Daphnia magna (Wetton and Mullee, 2001). No toxicity to Daphnia was observed due to an EC50 > 100 mg/L. The same conclusion can be done for acute toxicity to algae, considering the available data, which is also a study report describing a GLP compliant guideline study (OECD guideline 201 and EU Method C.3) with Desmodesmus subspicatus (Neuhahn, 2011). The EC50, based on both, growth rate and biomass, are greater than 100 mg/L. No experimental data regarding long-term toxicity to aquatic organisms is available. For all three species only a QSAR prediction could be performed resulting in a so-called Chronic Values (ChV) for fish (158.07 mg/L), Daphnia (64.00 mg/L) and green algae with 70.66 mg/L. No GLP criteria are applicable for the usage of this tool, but due to the fact that it is a scientifically accepted calculation method the estimations performed are reliable with restrictions, but cannot be used for the chemical safety assessment and hence cannot reject the classification & labelling status of the substance.

Conclusion on classification

The available acute toxicity data to fish leads to the classification and labelling of the test substance according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council. The classification is "Aquatic Chronic 2" with Hazard statement 411 (H411; Toxic to aquatic life with long lasting effects) and Precautionary statements P273 (Avoid release to the environment), P391 (Collect spillage) and P501 (Dispose of contents/container in accordance with local/regional/national/international regulations). The corresponding label is pictogram GHS 09 ("fish and tree").