Registration Dossier
Registration Dossier
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EC number: 936-795-4 | CAS number: -
Genetic toxicity: in vitro
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
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate in study report
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 864970-33-2
- Cas Number:
- 864970-33-2
- IUPAC Name:
- 864970-33-2
Constituent 1
Method
- Target gene:
- Histidine coding gene for Salmonella Typhimurium and Tryptophan coding gene for Escherichia Coli
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 5000 µg/plate
Results and discussion
Test resultsopen allclose all
- Species / strain:
- 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
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
PACTT, 2 Na organic part was considered to be non mutagenic under the conditions of this test. As PACTT, 2 Na mineral part, Sodium Bromide, is not either classified as mutagenic, the multi-constituent substance has not to be classified as mutagenic.
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