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 aquatic ecotoxicity data have been read across from studies on the acute toxicity to Daphnia and fish and algal growth inhibition of aluminum, benzoate C16-18-fatty acids complexes. These proprietary studies were conducted as water accommodated fractions (WAF) at a GLP-compliant laboratory following OECD guidelines in standard water with a hardness of approximately 150 mg/L CaCO3. The studies showed no effects at nominal loading rates of up to 100 mg/L WAF. According to REACH Chapter R7b (ECHA 2012), “the acute lethal loading level…cannot be used to derive a PNEC, since partitioning in the environment will make the comparison with a PEC meaningless”. Due to the low water solubility, the substances were tested as water accommodated fractions and therefore no aquatic PNECs have been derived.

The substance shows no toxicity at its limit of solubility, has very low vapour pressure, a low potential for bioaccumulation, is readily biodegradable and is not applied directly to soil. Therefore, 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. In addition, while adsorption of hydrated aluminium oxide, a by-product of degradation, is possible to sediment, this is not expected to be hazardous.

Conclusion on classification

(Benzoato-O,O')hydroxy(octadecanoato-O,O')aluminium is predicted to show no acute toxicity to aquatic organisms at up to 100 mg/L (WAF) and therefore does not meet the criteria for classification as acutely toxic to the aquatic environment under the DSD or the CLP.

Chronic aquatic toxicity data are only available for algae. These data would not result in a chronic classification according to CLP guidance version 4.1 (June 2015). In addition, the substance has been shown to be readily biodegradable, with a low potential for bioaccumulation. As the substance does not show acute toxicity at up to 100 mg/L (WAF), the substance does not meet the criteria for chronic toxicity to aquatic organisms.