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EC number: 900-050-1 | 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:
- 1990-06-19 to 1990-07-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it is in compliance with GLPs and an accepted concurrent guideline for reversion assays
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1990-06-19 to 1990-07-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it is in compliance with GLPs and an accepted concurrent guideline for reversion assays
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Not applicable
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, and TA 100
- Additional strain / cell type characteristics:
- other: uvrB and rfa deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- ± S9 from aroclor induced rat liver
- Test concentrations with justification for top dose:
- Range-finding preliminary toxicity test: 5, 50, 500, and 5000 µg/plate
Mutation test: 1.5, 5, 15, 50, 150, and 500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine; n-ethyl-n'-nitro-n nitrosoguanidine; 2-nitrofluorene; 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
DURATION
- Exposure duration: 3 days
- Expression time (cells in growth medium): 10 hours
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- The test material is considered mutagenic if two independent treatments with any bacterial strain produce a two-fold increase in the number of revertant colonies over concurrent solvent controls, accompanied by some evidence of a positive dose-response relationship.
The test material is not considered mutagenic if treatment at any dose level with any bacterial strain does not result in reproducible increases of revertant colonies (1.5 times) over the concurrent solvent controls - Statistics:
- Statistical methods were not employed in the study .
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- PRELIMINARY RANGE-FINDING/SCREENING STUDIES: 1-hexene when tested at 5000 µg/plate was found to be toxic to the S. typhimurium strains. Hence the 500 µg/plate dose was the highest dose tested in the mutagenicity test.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- negative
1-Hexene is not mutagenic when tested with Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538, with or without metabolic activation. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 of S. typhimurium were exposed to 1-hexene in DMSO at concentrations of 1.5, 5, 15, 50, 150, or 500 µg/plate in the presence and absence of mammalian metabolic activation using the plate-incorporation method.
1 -Hexene was tested up to cytotoxic concentrations (5000 µg/plate) in a preliminary range-finding study and based on the results, the above mentioned concentrations were tested in the mutagenicity study. No substantial increases in revertant colony numbers of any of the five tester strains were observed subsequent to treatment with 1-hexene at any dose level, either in the presence or absence of metabolic activation.There was no evidence of induced mutant colonies over background or a concentration related positive response observed during the study. The positive controls induced the appropriate responses in the corresponding strains.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it is in compliance with GLPs and an accepted concurrent guideline for reversion assays.
No significant effects were observed at any dose level, with or without metabolic activation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hex-1-ene
- EC Number:
- 209-753-1
- EC Name:
- Hex-1-ene
- Cas Number:
- 592-41-6
- Molecular formula:
- C6H12
- IUPAC Name:
- hex-1-ene
- Reference substance name:
- 1-hexene
- IUPAC Name:
- 1-hexene
- Details on test material:
- - Name of test material (as cited in study report): 1-Hexene
- Molecular formula (if other than submission substance): CH3CH2CH2CH2CH=CH2
- Substance type: C6 alpha olefin
- Physical state: Liquid
- Analytical purity: 99.06%
- Lot/batch No.: 300-892
- Expiration date of the lot/batch: 1995-05-30
- Stability under test conditions: Not determined
- Storage condition of test material: Room temperature in the dark under dry nitrogen
- Other: Stored in solvent dimethylsulphoxide
Constituent 1
Constituent 2
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, and TA 100
- Additional strain / cell type characteristics:
- other: uvrB and rfa deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- ± S9 from aroclor induced rat liver
- Test concentrations with justification for top dose:
- Range-finding preliminary toxicity test: 5, 50, 500, and 5000 µg/plate
Mutation test: 1.5, 5, 15, 50, 150, and 500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine; n-ethyl-n'-nitro-n nitrosoguanidine; 2-nitrofluorene; 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
DURATION
- Exposure duration: 3 days
- Expression time (cells in growth medium): 10 hours
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- The test material is considered mutagenic if two independent treatments with any bacterial strain produce a two-fold increase in the number of revertant colonies over concurrent solvent controls, accompanied by some evidence of a positive dose-response relationship.
The test material is not considered mutagenic if treatment at any dose level with any bacterial strain does not result in reproducible increases of revertant colonies (1.5 times) over the concurrent solvent controls - Statistics:
- Statistical methods were not employed in the study .
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- PRELIMINARY RANGE-FINDING/SCREENING STUDIES: 1-hexene when tested at 5000 µg/plate was found to be toxic to the S. typhimurium strains. Hence the 500 µg/plate dose was the highest dose tested in the mutagenicity test.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No significant effects were observed at any dose level, with or without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- negative
1-Hexene is not mutagenic when tested with Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538, with or without metabolic activation. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 of S. typhimurium were exposed to 1-hexene in DMSO at concentrations of 1.5, 5, 15, 50, 150, or 500 µg/plate in the presence and absence of mammalian metabolic activation using the plate-incorporation method.
1 -Hexene was tested up to cytotoxic concentrations (5000 µg/plate) in a preliminary range-finding study and based on the results, the above mentioned concentrations were tested in the mutagenicity study. No substantial increases in revertant colony numbers of any of the five tester strains were observed subsequent to treatment with 1-hexene at any dose level, either in the presence or absence of metabolic activation.There was no evidence of induced mutant colonies over background or a concentration related positive response observed during the study. The positive controls induced the appropriate responses in the corresponding strains.
This study received a Klimisch score of 1 and is classified as reliable without restriction because it is in compliance with GLPs and an accepted concurrent guideline for reversion assays.
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