Registration Dossier

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 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 needs to be dervied

Conclusion on classification

Classification

T003063 is not considered to be biodegradable. 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. Classification should only be based on toxic responses observed in the soluble range, therefore the substance is not expected to be chronically toxic to aquatic organisms either based on the results of the algae study (NOEC >= solubility limit).

T003063 has a log Kow of 7.5. Substances with log Kow between 4.5 and 6 are considered likely to be highly accumulating; however, no substantial bioconcentration is assumed for compounds having log Kow with values less than 4.5 or greater than 6. For substances having log Kow greater than 6, a gradual decrease of the BCF is observed and it has been hypothesized within the published literature that a high log Kow is more an effect of solubility than a tendency of the substance to be lipophilic. Chemicals with log Kow > 6 to 7 showed decrease of uptake efficiency to mammalian organisms (Kelly et al, 2004). For fish, a log Kow of > 10 is applied as one of the indicators for not being B/vB in REACh Guidance R.11.

Based on the available data, the substance is classified as aquatic chronic category 4.