Registration Dossier
Registration Dossier
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EC number: 470-470-3 | CAS number: 9022-75-7
Genetic toxicity: in vitro
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other 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:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
Test material
Constituent 1
Method
- Target gene:
- Not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- not applicable
- Test concentrations with justification for top dose:
- Preliminary test: 10, 100, 500, 1000, 2500 and 5000 µg/plate
Main experiment:
- 0.82, 2.47, 7.41, 22.22 and 66.67 µg/plate, for the TA 102 strain in the first experiment
- 2.47, 7.41, 22.22, 66.67 and 200 µg/plate, for the TA 1535 and TA 1537 strains in the first experiment
- 0.27, 0.82, 2.47, 7.41 and 22.22 µg/plate, for the TA 98 and TA 100 strains in both experiments as well as for the TA 1535 and TA 102 strains in the second experiment
- 0.09, 0.27, 0.82, 2.47 and 7.41 µg/plate, for the TA 1537 in the second experiment
Results and discussion
Test resultsopen allclose all
- Species / strain:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- mainly at dose-levels ≥ 22.22 µg/plate, depending on the tester strains and the experiments.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- mainly at dose-levels ≥ 7.41 µg/plate, depending on the tester strains and the experiments
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
See file attached
Applicant's summary and conclusion
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