Registration Dossier
Registration Dossier
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EC number: 604-776-7 | CAS number: 151213-15-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
A bacterial reverse mutation assay with S. typhimurium was conducted using Bay Z 7906 concentrations from 0.00005 to 5000 µg per plate. Doses up to and including 0.0016 μg/plate did not cause any bacteriotoxic effects. Higher doses had a strong, strain–specific bacteriotoxic effect. Therefore they could only partly be used for assessment purposes up to and including 0.016 μg per plate.
Bay Z 7906 was not mutagenic with and without metabolic activation in the S. typhymurium strains TA 1535, TA 100, TA 1537 and TA 98. However, evidence of mutagenic activity of Bay Z 7906 was seen on S. typhymurium TA 102 without and with S9 mix, with 0.005 µg/plate being the lowest reproducible effective dose.
In summary, in the Salmonella/microsome test Bay Z 7906 induced mutations in the S. typhimurium strain TA 102. This effect is consistent with observations made with most other fluorochinolones that also potently inhibit the bacterial gyrase enzyme. The selective effect on TA 102 is due to this being the only tester strain of commonly used Salmonella strains with a functional excision repair system. This system is likely to cause increased replication errors as a response to the quinolone induced DNA damage (mechanistically via inhibiting bacterial gyrase enzyme).
Short description of key information:
Gene mutation in vitro (bacterial reverse mutation assay, GLP, OECD TG 471, EU Method B.14, OPPTS 870.5265): negative in the Salmonella typhimurium strains TA 1535, TA 1537, TA 100 and TA 98 with and without S9 mix; positive in the Salmonella typhimurium strain TA 102 with and without S9 mix
[Bayer AG, Report No. PH 26942, 1997-12-15]
Endpoint Conclusion: Adverse effect observed (positive)
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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