Registration Dossier
Registration Dossier
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EC number: 442-680-5 | CAS number: 443688-20-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 13th to 14th, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2000/32/EC
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Kanpoan no 287
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF (February 24, 2000)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Red LF 6339
- IUPAC Name:
- Red LF 6339
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Due to migration, the value was transferred to one of the current document's attachments
- Test concentrations with justification for top dose:
- Concentration range in the main test: 312.5, 625, 1250, 2500 and 5000 µg/plate (with and without metabolic activation)
5000 μg/plate was chosen as maximal concenration as no relevant toxic effects were observed
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Remarks:
- without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- other: 2-aminoanthracene, 1.5 μg/plate TA1537, TA98, TA100 and 20 μg/plate E.coli WP2 in DMSO
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: three plates
- Number of experiments: plate incorporation test (first experiment with and without metabolic activation, second experiment without activation) and pre-incubation test (second experiment with metabolic activation).
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 30 minutes
- Exposure duration/duration of treatment: 48 hours at 37 °C in the dark
DATA RECORDING: colonies were counted electronically or manually
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- negative with and without metabolic activation
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