Registration Dossier
Registration Dossier
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EC number: 212-477-4 | CAS number: 821-41-0
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:
- 11.12.2002 to 24.02.2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hex-5-en-1-ol
- EC Number:
- 212-477-4
- EC Name:
- Hex-5-en-1-ol
- Cas Number:
- 821-41-0
- Molecular formula:
- C6H12O
- IUPAC Name:
- hex-5-en-1-ol
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA98, 100, 102, 1535, 1537
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 50 - 5000 µg/plate
50 - 1000 µg/plate for TA 98 (without S9 mix) - Vehicle / solvent:
- DMSO
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Details on test system and experimental conditions:
- Two independent tests were conducted, one preincubation test and one plate incorporation test.
Results and discussion
Test results
- Key result
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: >= 1600 µg/plate
- Remarks on result:
- other: other: Salmonella typhimurium TA98, 100, 102, 1535, 1537
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- 5-Hexen-1-ol did not induce a mutagenic effect in all 5 S. typhimurium strains tested. It is therefore not considered to be a bacterial mutagen. Thus, the available data on mutagenicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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