Registration Dossier
Registration Dossier
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EC number: 453-850-3 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 92/69/EWG, B.14 (Ames-Test)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Method
Species / strain
- Species / strain / cell type:
- bacteria, other: sat TA 98, 100, 102, 1535, 1537
- Metabolic activation system:
- Mit Aroclor 1254 induzierter Rattenleber S9-Mix. "ENGLISH" S9 mix of rat liver induced with Aroclor 1254
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): .4 ... 1.4 µg/plate
Concentration range in the main test (without metabolic activation): .4 ... 1.4 µg/plate - Vehicle / solvent:
- Solvent: DMSO
- Details on test system and experimental conditions:
- Concentration of the test substance resulting in precipitation: 5000 µg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1.6 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1.6 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1.4 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (>= 1.4 µg/plate)
- Additional information on results:
- Observations:
Tri-Fluorchinoloncarbonsäure wurde im
Plattenincorporationstest (als Vorversuch ausgewiesen) an
Dosismengen bis einschließlich 5,0 µg/Platte an fünf
Stämmen auf mutagene Effekte geprüft. Eine unabhängige
Wiederholung wurde anschließend als Preincubationstest
(ausgewertet als Hauptversuch) mit dem Stamm TA 102
durchgeführt.
Eine Dosis bis einschließlich 1,2 µg/Platte verursachte
keine bakterientoxische Effekte. Die Bakterienzahl blieb
unverändert und es wurde keine Wachstumshemmung beobachtet.
Bei 1,4 µg/Platte weist die Substanz einen nur schwachen,
stammspezifischen bakterientoxischen Effekt auf. Wegen der
Schwäche des Effektes konnte diese Dosis dennoch zur
Bewertung herangezogen werden.
Ein Hinweis auf eine mutagene Wirkung wurde am Stamm TA 102
durch einen biologisch relevanten Anstieg von mutanten
Zellen im Vergleich zur entsprechenden Negativ-Kontrolle
beobachtet. Dieser positive Befund wurde in Gegenwart und in
Abwesenheit von S9-Mix im Incorporations- sowie im
Preincubationstest erhalten. Die niedrigste reproduzierbare
Wirksamkeitsdosis war 0,4 µg/Platte.
"ENGLISH"
Tri-fluoroquinolone carboxylic acid was tested for mutagenic
effects in the plate incorporation test (stated to be a
pretest) on five strains in dose quantities up to and
including 5.0 µg/plate. An independent repetition was
subsequently performed as a preincubation test (evaluated as
the main test) with the strain TA 102.
A dose up to and including 1.2 µg/plate did not induce any
bacterial-toxic effects. The bacterial count remained
unchanged and no growth inhibition was observed.
At 1.4 µg/plate the substance reveals only a weak,
strain-specific bacterial-toxic effect. In spite of the
weakness of the effect, this dose could still be included
for purposes of evaluation.
An indication of a mutagenic effect was observed in strain
TA 102 by a biologically relevant increase in mutant cells
in comparison with the corresponding negative control. This
positive finding was obtained in the incorporation and in
the preincubation test in the presence and absence of S9
mix. The lowest reproducible toxic dose was 0.4 µg/plate. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
positive without metabolic activation
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