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Additional information

In vitro gene mutation test in bacteria

The mutagenic activity of AC-6000 was examined in the reverse mutation test by using bacterial strains Salmonella typhimurium TA100, TA1535, TA98 and 1537 and Escherichia coli WP2uvrA (Hita Laboratory, 2006). The GLP-compliant study was performed comparable to OECD guideline 471. The reverse mutation test was composed of a dose range finding and a main test. The pre-incubation method was used for all bacterial strains in both the presence and the absence of metabolic activation using the following concentrations: 4.88, 19.5, 78.1, 313, 1250 and 5000 µg/plate (dose range finding test) and 313, 625, 1250, 2500 and 5000 µg/plate (main test). In both the dose range finding test and the main test, the number of revertant colonies in the substance treatment groups in all test strains with and without S-9 mix was less than twice that in the solvent control. Bacterial growth inhibition and precipitation of the substance were not observed at any doses in the groups of treatment in all test strains with and without S-9 mix. Therefore it is concluded that the mutagenic activity of AC-6000 is considered negative under the test conditions employed.

In vitro chromosome aberration test with mammalian cells

The ability of AC-6000 to induce chromosomal aberrations was investigated by using Chinese hamster lung fibroblasts (CHL/IU cells) in a study comparable to OECD guideline 473 (Hita Laboratory, 2007). Based on the results of cell growth inhibition test, the concentrations of the test substance in the chromosomal aberration test were set at 870, 1740 and 3480 µg/mL in short-term treatments (6 hours) without and with S-9 mix and in a 24 hours continuous treatment. In the observation, the frequencies of cells with structural aberrations and numerical aberrations were scored.

Cytotoxicity was not observed. Precipitation of the test substance was observed at all concentrations. The frequencies of cells with structural and numerical aberrations were below 5% at all tested concentrations of the test substance in all treatment methods. It was concluded that AC-6000 did not induce chromosomal aberrations under the present test conditions.

 


Short description of key information:
The substance was negative both in an Ames test and in an in vitro chromosomal aberration test.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the results of the in vitro tests, the substance does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.