Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no data: aquatic toxicity unlikely

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no exposure of sediment expected

Sediment (marine water)

Hazard assessment conclusion:
no exposure of sediment expected

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no exposure of soil expected

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential to cause toxic effects if accumulated (in higher organisms) via the food chain

Additional information

Three short-term studies were available for the three standard aquatic organisms (fish, daphnia and algae). All three studies showed no toxicity up to the highest concentration tested being 100 mg/L. The substance did not show toxic effects to fish, aquatic invertebrates and algae at its saturation level in the respective test medium. PNECs could not be derived as the substance showed no toxic effects in studies performed in the range of its solubility. At the present state of knowledge, no negative ecological effects are expected. The substance is not expected to pose an unacceptable risk to the aquatic environment since it is not harmful to aquatic organisms up to its limit of solubility in water and there is expected to be very low aquatic exposure based on its very low solubility in water.

No toxicity was observed in a OECD 209 study at the highest dose tested. No PNEC can thus be derived.

As there are no tests on sediment and soil dwelling organisms available, and as no PNEC aquatic could be derived, no PNEC values for soil and sediment can be derived either by using assessment factors or by the equilibrium partitioning method.

The substance is not readily biodegradable, therefore there is some potential for the substance to persist in the environment.

Although the screening log Kow of the substance is >=4, the substance is shown to be unstable. As no toxic effects have been observed to fish, aquatic invertebrates and algae during the experimental testing, it is expected that the substance has no potential to cause toxic effects if accumulated via food chain. Consequently there is no need to perform an assessment for secondary poisoning.

Conclusion on classification

Classification

No toxicity of the substance in the range of its solubility has been recorded in any of the three acute studies. In all trophic levels no toxic effects occurred up to the limit of solubility in the respective test media. Therefore, the test substance can be considered as not toxic to aquatic organisms and not posing an aquatic toxicity hazard. As the substance is considered as poorly water-soluble and does not rapidly biodegrade, the "safety net" classification does apply as the log Kow is =>4 indicating a potential for bioaccumulation (although questionable as the substance is unstable). Therefore, a conservative approach is followed and it is proposed that the substance is classified Chronic Cat. 4.


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