Registration Dossier
Registration Dossier
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EC number: 453-060-9 | 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.13, 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:
- Aroclor 1254 induzierter S9-Mix "ENGLISH" Aroclor 1254-induced S9 mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: Deionisiertes Wasser
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1581 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 1581 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- with
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 500 µg/plate)
- Species / strain:
- other: as specified above
- Metabolic activation:
- without
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 500 µg/plate)
- Additional information on results:
- Observations:
Ausfällung:
Bis 5000 µg/Platte (Tube) wurde bei allen geprüften Stämmen
keine Ausfällung beobachtet.
Plattenincorporationstest (ausgewertet als Vorversuch):
Bis einschließlich 1581 µg/Platte wurden keine
bakterientoxische Effekte beobachtet. Die Gesamtzahl an
Bakterien/Platte war mit denen der Negativkontrolle
vergleichbar oder sie unterschieden sich nur unwesentlich.
Es wurde auch keine Wachstumshemmung beobachtet. Bei 5000
µg/Platte wurden lediglich schwache, stammspezifische,
bakterientoxische Effekte beobachtet.
Keiner der fünf geprüften Stämme zeigte sowohl mit als auch
ohne S9-Mix im Vergleich zur Negativkontrolle eine
dosis-bezogene, biologisch relevante Zunahme von mutanten
Zellen.
Preinkubationstest (ausgewertet als Hauptversuch):
Bis zu und einschließlich 500 µg/Tube wurden keine
bakterientoxischen Effekte beobachtet. Die
Gesamtbakterienzahl war der der Negativkontrolle
vergleichbar oder unterschied sich nur unwesentlich. Es
wurde keine Wachstumshemmung beobachtet. Höhere Dosismengen
zeigen einen stammspezifischen bakterientoxischen Effekt.
Daher konnten sie nur partiell bis und einschließlich
5000 µg/Tube in die Auswertung einbezogen werden.
Keiner der fünf Stämme wies im Vergleich zur
Negativkontrolle eine dosis-abhängige und biologisch
relevante Zunahme an mutanten Zellen auf. Damit stimmen die
Ergebnisse mit denen des Plattenincorporationstests überein.
"ENGLISH"
Precipitation:
Up to 5000 µg/plate (tube) no precipitation was observed in
any of the tested strains.
Plate incorporation test (evaluated as a pretest):
No bacteria-toxic effects were observed up to and including
1581 µg/plate. The total count of bacteria/plate was
comparable with that of the negative control or they
only differed insignificantly. No growth inhibition was
observed. At 5000 µg/plate only weak, strain-specific,
bacteria-toxic effects were observed.
None of the five tested strains revealed in comparison
with the negative control, either with or without S9 mix, a
dose-related, biologically relevant increase in mutant
cells.
Preincubation test (evaluated as a main test):
No bacteria-toxic effects were observed up to and including
500 µg/tube. The total bacteria count was comparable with
the negative control or only differed insignificantly. No
growth inhibition was observed. Higher dose quantities
reveal a strain-specific, bacteria-toxic effect.
Consequently, they could only be partially, up to and
including 5000 µg/tube, included in the evaluation.
In comparison with the negative control, none of the five
strains revealed a dose-dependent and biologically relevant
increase in mutant cells. The results therefore accord with
those from the plate incorporation test. - Remarks on result:
- other: other: preliminary test
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
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