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Micronucleus test:

The test item MeNigu did not induce micronuclei in V79 cells (Chinese hamster cell line) in vitro in the absence and the presence of metabolic activation. Therefore, MeNigu is considered to be non-mutagenic in this in vitro test system when tested up to the highest required test item concentration.

Chromosome aberration test:

In both the experiments performed without and with metabolic activation, no biological relevant increase in the number of metaphases containing specific chromosomal aberrations was observed. It is concluded that under the given experimental conditions no evidence of clastogenic effects was obtained in Chinese hamster ovary cells in vitro treated with CA 2342 A.

Ames test:

With and without metabolic activation, none of the tested concentrations of CA 2342 A led to an increase in the incidence of either histidine- or tryptophan-prototrophic mutants by comparison with the negative control. Therefore CA 2342 A (Intermediate of CGA 293343) and its metabolites did not induce gene mutations in the strains of S. typhimurium and E. coli used.

Short description of key information:
Three in-vitro tests on the genetic toxicity of the test item CA 2342 were performed in the laboratories of Ciba and RCC (both Switzerland).
1. Micronucleus test: testing facility RCC (Switzerland); highest test item concentration tested 1200 µg/ml; year 2005
2. Chromosome aberration test hamster cells: testing facility Ciba (Switzerland); highest test item concentration 2650.00 µg/ml; year 1996
3. Ames test: testing facility RCC (Switzerland); highest test item concentration 5000.0 µg/plate; year 1996

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

All of the three in-vitro genotixicity performed led to a negative result. Therefore EU or GHS classification of CA 2342 A as to its genotoxic properties is not required.

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