Introduction – Mutagenic potential – STABILGREEN® K

Two valid experiments were performed.

The study procedures described in this report were based on the most recent OECD and EC guidelines.

The test item STABILGREEN®K (Polyglyceryl-4 Oleyl Ether, Dioleyl Phosphate) was tested in the Salmonella typhimurium reverse mutation assay with five strains of Salmonella typhi- murium (TA97a, TA98, TA100, TA102 and TA1535). The test was performed in two experiments in the presence and absence of S9-mix (rat liver S9-mix induced by Aroclor 1254).

In the first experiment, STABILGREEN®K (Polyglyceryl-4 Oleyl Ether, Dioleyl Phosphate) (dissolved in DMSO) was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix (0.74 % final concentration in the treatment) in the strains TA97a, TA98, TA100, TA102 and TA1535 using the plate incorporation method. STABILGREEN®K (Polyglyceryl-4 Oleyl Ether, Dioleyl Phosphate) showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item STABILGREEN®K (Polyglyceryl-4 Oleyl Ether, Dioleyl Phosphate) showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation.

The results of this experiment showed that none of the tested concentrations showed a significant increase in the number of revertant in all tested strains, in the presence and the absence of metabolic activation.

On the base of the first experiment, STABILGREEN®K (Polyglyceryl-4 Oleyl Ether, Dioleyl Phosphate) was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix (0.74% final concentration in the treatment) in all bacteria strain using the pre- incubation method. STABILGREEN®K (Polyglyceryl-4 Oleyl Ether, Dioleyl Phosphate) showed no precipitates on the plates at any of the concentrations. The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains.

The results of this experiments showed that the test item STABILGREEN®K (Polyglyceryl-4 Oleyl Ether, Dioleyl Phosphate) caused no increase in the number of revertant in all bacteria strains compared to the solvent control, in both the absence and presence of metabolic activation. The test item STABILGREEN®K (Polyglyceryl-4 Oleyl Ether, Dioleyl Phosphate) did not induce a dose-related increase in the number of revertant colonies in all strains, in the presence and absence of metabolic activation.