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Additional information

The ames test and the in vitro mouse lymphoma assay results in a negative outcome of the test. However, in a further in vitro study the chromosome aberration test according to OECD 473, SymHelios 1031 induced structural chromosomal aberrations in cell without metabolic activation. Therefore, and in accordance with regulation (EC) 1907/2006 annex VIII an in vivo micronucleus assay becomes necessary and was performed following OECD guidance 474. I

It can be stated that under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse. In conclusion, SymHelios 1031 is considered not to induce mutagenicity in human cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to the result given above the substance has not to be classified according to regulation (EC) 1272/2008.