Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

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:
no potential for bioaccumulation

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 to fish, aquatic invertebrates 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.

As the substance is insoluble in water, concentrations which are toxic to aquatic organisms will not be reached. This is demonstrated in the available acute ecotoxicity studies. The substance will therefore not be classified for environmental hazards, based on the available information.

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. Consequently, definitive PNECs for T002326, being a substance with a low water solubility (Reingruber, 2016), cannot be dervided credibly from such data due to the lack of effects in the laboratory toxicity studies. Moreover, no long-term test has to be carried out for this substance since the log Kow is < 3 and the PEClocal/regional is < 1/100th of the water solubility.

It is concluded that T002326 does not pose a hazard, and a qualitative assessment is used as the technical basis supporting the risk assessment conclusion (i.e. the substance poses a negligible risk). Default PECs obtained from the EUSES model are below the ‘limit’ concentration at which no adverse effects are elicited, therefore further refinement of the exposure assessment is not be warranted.

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. Furthermore, the substance does not have a significant potential to bioaccumulate. Since the test substance showed no toxic effects within the range of solubility and is not bioaccumulative due to the log Kow of -0.078 no acute or chronic classification according to Regulation (EC) No 1272/2008 is justified. Although the substance is considered as poorly water-soluble and does not rapidly biodegrade, the "safety net" (Cat. chronic 4) also does not apply as the log Kow is =<4 indicating a low potential for bioaccumulation. In conclusion, none of the criteria of Regulation (EC) No 1272/2008 have been met. Therefore, it is proposed that the substance is not classified for environmental hazards.