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EC number: 218-871-2 | CAS number: 2269-22-9
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1988-12-06, 1989-03-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not GLP. According to guideline with minimal deviations, which do not impair the significance of the results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-butanol
- IUPAC Name:
- 2-butanol
- Reference substance name:
- Butan-2-ol
- EC Number:
- 201-158-5
- EC Name:
- Butan-2-ol
- Cas Number:
- 78-92-2
- Molecular formula:
- C4H10O
- IUPAC Name:
- butan-2-ol
- Test material form:
- other: clear colorless liquid
- Details on test material:
- - Name of test material (as cited in study report): Butanol secondaire (secondary butanol, 2-butanol)
- Substance type: organic
- Physical state: liquid, clear
- Storage condition of test material: protected from light and heat
- Other: soluble in water (12.5%), ethanol, DMSO, and vegetable oil
Constituent 1
Constituent 2
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA98, TA 100
- Additional strain / cell type characteristics:
- other: unable to synthesize histidin
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix from Aroclor 1254-induced rat liver (10%)
- Test concentrations with justification for top dose:
- 100, 500, 1000, 5000, and 10000 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: low solubility in water (12.5%)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- sodium azide
- Remarks:
- strains TA 100 and TA 1535: 5 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- strains TA98 and TA1538: 5 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- 9-aminoacridine
- Remarks:
- strain TA1537: 100 μg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- all strains 5 μg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation and in agar (plate incorporation)
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
- Expression time (cells in growth medium): 48 h
- Selection time in histidine-depleted medium: 48 h
- Fixation time (start of exposure up to fixation or harvest of cells): 48 h and 20 min
SELECTION AGENT (mutation assays): growth in absence of histidine
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- Cytotoxicity is determined by a reduction of the number of colonies in the plates with the test substance (TS) compared to that of a negative control without TS, and by the ability of the TS to inhibit growth of a bacterial lawn.
Genotoxicity is attributed when the number of revertant colonies is at least equal or double that of spontaneous revertants and when a concentration effect can be shown. Additionally, when the ratio number of revertants/nmole is more than 0.01 and the results are reproducible.
Results are expressed in number of colonies per plate (evaluation of cytotoxicity) and number of revertant colonies His+ per plate (evaluation of genotoxicity). - Statistics:
- Arithmetic mean and standard error ('e.s.m.' in the study)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 10000 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none reported
- Effects of osmolality: none reported
- Evaporation from medium: none reported
- Water solubility: 12.5%, DMSO used as solvent
- Precipitation: none reported
- Other confounding effects: none reported
ADDITIONAL INFORMATION ON CYTOTOXICITY: Viability of the TA100 strain was 100 % in the vehicle control and 100, 91, and 27 % at 1000, 5000, and 10000 μg/plate, respectively
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results
negative with and without metabolic activation
The secondary butanol in the Ames test is not mutagenic when used at 100, 500, 1000, 5000, and 10000 μg/plate
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