Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

Based on the biodegradation results from a structural analogue, aluminium salts of benzoate, C16-18 fatty acids complexes, the substance in an isolated form is expected to be readily biodegradable. However, based on the study conducted on the substance in situ in medicinal white oil, the substance in the form in which it is marketed is not readily biodegradable. As contradictory data are available on the biodegradation of the substance in different forms (isolated from carrier versus in situ in base oil), the data on the substance in the form in which it is marketed and used has been used taken into account for any hazard/risk/persistence assessment. Therefore, it is concluded that the substance is not readily biodegradable.

The water solubility of the substance as a 50% w.w. concentration in pharmaceutical white oil has been determined to be less than 0.00015 g/L and therefore, the hydrolysis and biodegradation in water and sediment (simulation tests) studies have been waived.

The substance is not considered to bioaccumulate as, in the environment, the substance will dissociate and degrade into inorganic aluminium species and fatty acids. The fatty acids are natural substances with a long history of safe use in foods, while aluminium is expected to have a low potential for bioaccumulation, with BCF of around 36 at pH 7.2 in freshwater fish (Cleveland et al 1991).

In realistic use scenarios, the thickeners will be contained in a base oil matrix and, given the very low solubility of the substance in water, the concentrations of the substance which would be available for adsorption to soil or sediment are limited. As such, the adsorption/ desorption endpoint and, given that direct and indirect exposure of soil is not expected, the biodegradation in soil endpoint have been waived.