Registration Dossier
Registration Dossier
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EC number: 454-720-9 | CAS number: 161596-47-0
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 aus Rattenleber "ENGLISH" Aroclor 1254 induced S9 mix of rat liver
- 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: DMSO
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)
- Additional information on results:
- Observations:
Ausfällung:
Bis 5000 µg/Platte wurde keine Ausfällung beobachtet.
Plattenincorporationstest :
Bis einschließlich 500 µg/Platte wurden keine
bakterientoxische Effekte beobachtet. Ab 1581 µg/Platte
wurden bakterientoxische Effekte beobachtet.
Nur TA 1537 zeigte sowohl mit als auch ohne S9-Mix im
Vergleich zur Negativkontrolle keine dosisbezogene,
biologisch relevante Zunahme von mutanten Zellen.
Der Test zeigt das die Substanz mutagenes Potential besitzt.
"ENGLISH"
Precipitation:
No precipitation was observed up to 5000 µg/plate.
Plate incorporation test:
No bacterial toxic effects were observed up to and including
500 µg/plate. Bacterial toxic effects were observed as from
1581 µg/plate.
Only TA 1537 did not exhibit any dose-related, biologically
relevant increase in mutant cells in comparison with the
negative control both with and without S9-mix. The test
shows that the substance possesses a mutagenic potential. - Remarks on result:
- other: other: main 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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