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A guideline bacterial mutagenicity test (OECD TG 471) in Salmonella typhimurium strains TA100, TA 1535, TA 1537 and TA 98 as well as Escherichia coli strain WP2 uvr A was performed with the test substance in concentrations up to 5000 µg/plate with and without metabolic activation. The test substance was not mutagenic under these conditions. Valid positive controls were performed.

The ability of the test substance to induce chromosome aberrations in cultured peripheral human lymphocytes was investigated in a guideline study (OECD TG 473).

The number of cells with chromosome aberrations found in the solvent control cultures was within the laboratory historical control data range. Positive control chemicals, mitomycin C and cyclophosphamide, both produced a statistically significant increase in the incidence of cells with chromosome aberrations, indicating that the test conditions were adequate and that the metabolic activation system (S9-mix) functioned properly.

Terate® 091 Residue did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix, in either of the two independently repeated experiments.

No effects of Terate® 091 Residue on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Therefore it can be concluded that Terate® 091 Residue does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberrations under the experimental conditions described in this report.

Finally, it is concluded that this test is valid and that Terate® 091 Residue is not clastogenic in human lymphocytes under the experimental conditions described in the report.

The mutagenic activity of the test substance was evaluated in a guideline in vitro mammalian cell gene mutation test with L5178Y mouse lymphoma cells (OECD TG 476). Mouse Lymphoma cells (L5178Y/TK+/- 3.7.2C) were treated with the test substance at 8 concentrations in the range of 0.03 to 333 µg/ml. Precipitation in the exposure medium was observed at dose levels of 100 µg/ml and above. The spontaneous mutation frequencies in the solvent-treated control cultures were between the minimum and maximum value of the historical control data range and within the acceptability criteria of this assay. Valid positive controls were performed.

A negative study outcome is reported, with or without metabolic activation, indicating that the test item is not

mutagenic under the conditions tested.


Short description of key information:
Negative results in: in vitro bacterial mutagenicity test, in vitro chromosome aberration test in cultured peripheral human lymphocytes, in vitro mammalian cell gene mutation test with L5178Y mouse lymphoma cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Due to the negative outcomes of the reported studies, the test substance does not have to be classified as mutagenic according to Regulation (EC) No. 1272/2008.