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EC number: 298-697-1 | CAS number: 93821-12-6
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:
- 1980-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study report is classified as reliable with restrictions because while there is no statement regarding whether these studies were conducted according to GLPs or equivalent, the study appears to have been conducted in general accordance with OECD 471 guidelines.
- 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:
- 1980-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study report is classified as reliable with restrictions because while there is no statement regarding whether these studies were conducted according to GLPs or equivalent, the study appears to have been conducted in general accordance with OECD 471 guidelines.
- 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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction obtained from liver homogenate from Arochlor induced rats
- Test concentrations with justification for top dose:
- 0, 0.2, 2.0, 20, 200, and 2000 micrograms/plate
- Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Acetone
Justification for choice of solvent/vehicle: Not reported - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: 4-nitroquinoline-N-oxide and sodium azide also used.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours at 37 degrees Celsius
- Expression time (cells in growth medium): Not reported
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): Not applicable
SELECTION AGENT (mutation assays): Not reported
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: Not reported
DETERMINATION OF CYTOTOXICITY
- Method: Not reported
OTHER EXAMINATIONS: Not applicable - Evaluation criteria:
- Cultures were assessed for number of revertant colonies.
- Statistics:
- Not reported
- 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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Not applicable
- Effects of osmolality: Not applicable
- Evaporation from medium: Not applicable
- Water solubility:Not applicable
- Precipitation: Not applicable
- Other confounding effects: Not applicable
RANGE-FINDING/SCREENING STUDIES: Not reported
COMPARISON WITH HISTORICAL CONTROL DATA: Not reported
ADDITIONAL INFORMATION ON CYTOTOXICITY: Not reported - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
negative with metabolic activation
negative without metabolic activation
In an in vitro bacterial mutation assay, alpha C18 product was not mutagenic to five strains of Salmonella typhimurium or two strains of Escherichia coli in the presence or absence of metabolic activation.- Executive summary:
In a reverse gene mutation assay in bacteria, five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537, and TA1538) and 2 strains of Escherichia coli (WP2 and WP2uvrA) were exposed to alpha C18 product in acetone at concentrations of 0, 0.2, 2, 20, 200, or 2000 µg/plate in the presence and absence of mammalian metabolic activation using the plate-incorporation method. No increase in reverse mutation rate was noted in either assay in the presence or absence of metabolic activation. A preliminary study to assess bacterial cytotoxicity to determine appropriate doses was not performed.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because no GLP statement was included and although the study adhered to most of the principles outlined in OECD 471, a few study deficiencies were noted.
No tables are included because all results were negative.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Study performed before guideline introduced
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-octadecene
- IUPAC Name:
- 1-octadecene
- Reference substance name:
- Octadec-1-ene
- EC Number:
- 204-012-9
- EC Name:
- Octadec-1-ene
- Cas Number:
- 112-88-9
- Molecular formula:
- C18H36
- IUPAC Name:
- octadec-1-ene
- Details on test material:
- - Name of test material (as cited in study report): Alpha C18 Product
- Substance type: C18 alpha olefin
- Physical state: Liquid
- Analytical purity: Not reported
- Lot/batch No.: G.E.P. 78.4044
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Reported to be at least 4 hours
- Storage condition of test material: Not reported
- Other: Prepared in acetone
Constituent 1
Constituent 2
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 specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction obtained from liver homogenate from Arochlor induced rats
- Test concentrations with justification for top dose:
- 0, 0.2, 2.0, 20, 200, and 2000 micrograms/plate
- Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Acetone
Justification for choice of solvent/vehicle: Not reported
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Migrated to IUCLID6: 4-nitroquinoline-N-oxide and sodium azide also used.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours at 37 degrees Celsius
- Expression time (cells in growth medium): Not reported
- Selection time (if incubation with a selection agent): Not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): Not applicable
SELECTION AGENT (mutation assays): Not reported
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: Not reported
DETERMINATION OF CYTOTOXICITY
- Method: Not reported
OTHER EXAMINATIONS: Not applicable - Evaluation criteria:
- Cultures were assessed for number of revertant colonies.
- Statistics:
- Not reported
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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: Not applicable
- Effects of osmolality: Not applicable
- Evaporation from medium: Not applicable
- Water solubility:Not applicable
- Precipitation: Not applicable
- Other confounding effects: Not applicable
RANGE-FINDING/SCREENING STUDIES: Not reported
COMPARISON WITH HISTORICAL CONTROL DATA: Not reported
ADDITIONAL INFORMATION ON CYTOTOXICITY: Not reported - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
No tables are included because all results were negative.
Applicant's summary and conclusion
- Conclusions:
negative with metabolic activation
negative without metabolic activation
In an in vitro bacterial mutation assay, alpha C18 product was not mutagenic to five strains of Salmonella typhimurium or two strains of Escherichia coli in the presence or absence of metabolic activation.- Executive summary:
In a reverse gene mutation assay in bacteria, five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537, and TA1538) and 2 strains of Escherichia coli (WP2 and WP2uvrA) were exposed to alpha C18 product in acetone at concentrations of 0, 0.2, 2, 20, 200, or 2000 µg/plate in the presence and absence of mammalian metabolic activation using the plate-incorporation method. No increase in reverse mutation rate was noted in either assay in the presence or absence of metabolic activation. A preliminary study to assess bacterial cytotoxicity to determine appropriate doses was not performed.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because no GLP statement was included and although the study adhered to most of the principles outlined in OECD 471, a few study deficiencies were noted.
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