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Additional information

No internal genotoxicity studies were conducted with Flufenaminsäurebutylester.

Results of genotoxicity studies with Flufenaminsäurebutylester were published in literature.

Flufenaminsäurebutylester did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurium strains TA 97, TA 98, TA 100 and TA102) when tested up to the highest recommended dose level of 5.0 mg/plate in the absence or presence of extrinsic metabolic activation (S9 mix). Moreover, it was shown to be not clastogenic in an in vitro chromosome aberration test in Chinese hamster lung cells at the dosage of 4 -40 µg/mL.


Short description of key information:
No internal genotoxicity studies were conducted with Flufenaminsäurebutylester:
Results of genotoxicity studies with Flufenaminsäurebutylester were found in the literature (May 2011):

Bacterial reverse mutation assay (Ames test); dosage 0.5-5000 µg/plate with and without S9 mix: negative
(Li, D. et al. (1969); The Journal of Shenyang Pharmaceutical University - Shenyang Yaoke Daxue Xuebao v. 15, ISS 3, p. 209-210)

In vitro mammalian chromosome aberration test (CHL cells); dosages 4-40 µg/mL: negative
(Li, D. et al. (1969); The Journal of Shenyang Pharmaceutical University - Shenyang Yaoke Daxue Xuebao v. 15, ISS 3, p. 209-210)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Classification according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008 (CLP) is not required.

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