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 hazard identified

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 for bioaccumulation

Additional information

The available data fromfreshwater ecotoxicity studies on Daphnia (Harlan 2011), fish (Harlan 2011) and algal growth (Harlan 2012) for Diurea 8 in a grease base and for algal growth for the isolated Diurea 8 thickener (Harlan 2012)showed no effects at up to 100 mg/L loading rate. In accordance with REACH Chapter R7b (ECHA 2012), PNECs have not been derived for freshwater, marine or intermittent release as the substances were tested as water accommodated fractions.

Diurea 8 shows no toxicity at the limit of water solubility, exhibits very low predicted vapour pressure values and is not applied directly to soil. Diurea 8 only occurs in a grease designed to minimise leaching and is not expected to be available in the aquatic environment for adsorption or bioaccumulation. As such, the STP, sediment, soil, secondary poisoning and air PNECs were not derived due to a lack of potential exposure or a lack of identified hazard.

Reference

ECHA (2012) Guidance on information requirements and chemical safety assessment – Chapter R.7b: Endpoint Specific Guidance. European Chemicals Agency

Conclusion on classification

Diurea 8 showed no acute toxicity to aquatic organisms at up to 100 mg/L WAF and therefore it does not meet the criteria for classification as acutely toxic to the aquatic environment under the DSD or the CLP regulations.

Chronic aquatic toxicity data for Diurea 8 are only available for algae. These data would not result in a chronic classification under the 2ndATP to the CLP. Diurea 8 only occurs in a grease base and its octanol-water partition coefficient is estimated to be very high, indicating that it would reside in the grease base and not partition out into the aquatic environment. The substance is therefore not expected to be available for bioaccumulation. As the substance does not show acute toxicity at up to 100 mg/L, the substances does not meet the criteria for classification for chronic toxicity to aquatic organisms.

According to ECHA’s Guidance on information requirements and chemical safety assessment Part B: Hazard Assessment (2011), if no adverse effects have been observed in studies at the highest recommended concentrations/doses tested, this would normally indicate that no hazard has been identified and no DNEL or PNEC can be derived. Hence exposure assessment for that route of exposure, type of effect or protection target would not be needed.

Reference

ECHA (2011) Guidance on information requirements and chemical safety assessment – Part B: Hazard Assessment. European Chemical Agency