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EC number: 429-280-6 | CAS number: 151900-44-6
Clinical Observations: no clinical findings after treatment with the test substance in any rat of the 2000 mg/kg treatment group Tissue Tissue Cytotoxicity:
*= mean viability of cell preparation per dose group after perfusion #= relative to vehicle control animals The cell viability of vehicle controls was well within the range of defined cell quality criteria. The viability of liver, and stomach cells of rats exposed to Vulcuren VP KA 9188 was comparable to the respective control value. The same applied to the cells of the evaluated tissues of the positive control animals. Comet assay: Mean tail length per dose group
** p<0.01 (one-sided Mann-Whitney-Wilcoxon)
After administration of 2000 mg/kg Vulcuren VP KA 9188 to male rats the tail lengths of liver cells was comparable to values of the cells of the respective tissue vehicle control animals. The mean comet tail length of stomach cells of the rats treated at 2000 mg/kg Vulcuren VP KA 9188 were statistically significantly different as compared to concurrent control mean value. However, the observed tail length values of stomach cells are comparable to historical control data (see overall remarks). In addition, the individual animal tail length data (see overall remarks) showed that the statistically significant of mean values is not biologically relevant.
In summary, this difference is thus not considered to be biologically relevant.
The tail length of the positive control rats was clearly increased demonstrating the sensitivity of the test system for the detection of genotoxic effects.
Male Wistar rats, which were treated with 2000 mg/kg Vulcuren VP KA 9188, were evaluated in the Comet assay. The treated rats showed no signs of toxicity. After single application of 2000 mg/kg test substance the tail lengths of liver cells as well the tail lengths of stomach cells were not biologically relevant increased. Based on these findings, the author concluded that Vulcuren VP KA 9188 is non-gentoxic in the comet assay in vivo to liver and stomach cells of male Wistar rats (Lanxess GmbH, 2005).
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