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EC number: - | CAS number: -
Toxicological information
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 9, 2018 - March 6, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 6-Hydroxy-2,6-dimethylheptan-1-al
- Cas Number:
- 62439-42-3
- Molecular formula:
- C9H18O2
- IUPAC Name:
- 6-Hydroxy-2,6-dimethylheptan-1-al
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- E. coli WP2 uvrA: T/PE
S. typh. TA-97a: his D 6610
S. typh. TA-1535: his G 46
S. typh. TA-98: his D 3052
S. typh TA-100: his G 46
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 97a
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: livers of Aroclor 1254-treated adult rats
- method of preparation of S9 mix: The Regensys A solution was mixed with Regensys B. This solution was then mixed with S9 to create a 10% S9 stock solution.
- concentration or volume of S9 mix and S9 in the final culture medium: 0.5 mL
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability) - Test concentrations with justification for top dose:
- 0.05, 0.1, 0.5, 1, 5 uL/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Test substance was soluble in vehicle up to maximum dose concentration.
- Justification for percentage of solvent in the final culture medium: Vehicle control results showed results within historic ranges.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- sodium azide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: two
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 0.1 mL bacteria
- Test substance added in suspension
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48-72 hrs
- Harvest time after the end of treatment (sampling/recovery times): Plates were scored immediately, or kept at 2-8 degrees C until they could be scored.
FOR GENE MUTATION:
- Expression time (cells in growth medium between treatment and selection): 48-72 hrs
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: revertants per plate
METHODS FOR MEASUREMENTS OF GENOTOXICIY
The number of revertant colonies was measured using an Alphamager 220 fluroresence imager. - Rationale for test conditions:
- The concentrations was determined via a screening test. Concentrations of up to 50 uL/mL were tested in a solubility test, and the test substance was determined to be freely soluble up to those concentrations. A cytotoxicity screen showed that concentrations of up to 5 uL/plate were not cyctotoxic. Concentrations of 5, 1, 0.5, 0.1 and 0.05 uL/plate were therefore tested.
- Evaluation criteria:
- A two-fold increase in revertant colonies per plate (with or without metabolic activation) was considered a positive response. An absence of dose-related increase in all five test strains was considered a negative response.
- Statistics:
- Mean Colony Forming Units (CFUs) were calculated. The standard deviation and standard error of mean were also calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the main test, the S. typh. 97a test, with and without metabolic activiation was repeated due to the results of the first test being outside the range of historical vehicle controls.
In the repeat assay, the test for E. coli WP2 trp uvrA with metabolic activation failed due to being outside historical vehicle control ranges. The test was therefore repeated.
Any other information on results incl. tables
| Main Assay | |||||
| E. coli | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 37 | 5.8 | 2.4 | NA |
| 5 | + | 32 | 4.4 | 2.5 | 0.9 |
| 1 | + | 37 | 5.6 | 3.2 | 1 |
| 0.5 | + | 42 | 1 | 1.6 | 1.1 |
| 0.1 | + | 43.3 | 3.2 | 1.9 | 1.2 |
| 0.05 | + | 34 | 1.7 | 1 | 0.9 |
| Positive Control (2AA) | + | 164 | 27.4 | 11.2 | 4.4 |
| Vehicle | - | 32.3 | 2.9 | 1.2 | NA |
| 5 | - | 25.3 | 5.5 | 3.2 | 0.8 |
| 1 | - | 31 | 2.6 | 1.5 | 1 |
| 0.5 | - | 31.7 | 5.5 | 3.2 | 1 |
| 0.1 | - | 29.3 | 8.7 | 5 | 0.9 |
| 0.05 | - | 30.3 | 2.5 | 1.5 | 0.9 |
| Positive Control (MMS) | - | 625.8 | 34.2 | 14 | 19.4 |
| Main Assay | |||||
| S. typh. TA-97a | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 257.7 | 23.4 | 9.4 | NA |
| 5 | + | 256.3 | 25 | 14.4 | 1 |
| 1 | + | 268.3 | 17.5 | 10.1 | 1 |
| 0.5 | + | 272.3 | 22.2 | 12.8 | 1.1 |
| 0.1 | + | 272 | 24.6 | 14.2 | 1.1 |
| 0.05 | + | 263 | 25.9 | 15 | 1 |
| Positive Control (2AA) | + | 880.2 | 48.9 | 20 | 3.4 |
| Vehicle | - | 238.5 | 18.9 | 7.7 | NA |
| 5 | - | 168.7 | 14.5 | 8.4 | 0.7 |
| 1 | - | 232.3 | 4.6 | 2.7 | 1 |
| 0.5 | - | 224.3 | 21.9 | 12.7 | 0.9 |
| 0.1 | - | 228.7 | 11.9 | 6.9 | 1 |
| 0.05 | - | 228 | 15.5 | 9 | 1 |
| Positive Control (ICR191) | - | 703 | 104.3 | 42.6 | 2.9 |
| Repeat Main Assay | |||||
| S. typh. TA-97a | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 122.5 | 15.9 | 6.5 | NA |
| 5 | + | 121.7 | 12.1 | 7 | 1 |
| 1 | + | 139.3 | 20.8 | 12 | 1.1 |
| 0.5 | + | 118.3 | 6.8 | 3.9 | 1 |
| 0.1 | + | 128 | 11.3 | 6.5 | 1 |
| 0.05 | + | 127.7 | 14.8 | 8.4 | 1 |
| Positive Control (2AA) | + | 809.7 | 32.3 | 13.2 | 6.6 |
| Vehicle | - | 93.7 | 5 | 2 | NA |
| 5 | - | 88 | 14.7 | 8.5 | 0.9 |
| 1 | - | 104.7 | 15 | 8.6 | 1.1 |
| 0.5 | - | 96 | 8 | 4.6 | 1 |
| 0.1 | - | 89.3 | 10.7 | 6.2 | 1 |
| 0.05 | - | 84 | 7 | 4 | 0.9 |
| Positive Control (ICR191) | - | 783.8 | 63.2 | 25.8 | 8.4 |
| Main Assay | |||||
| S. typh. TA-1535 | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 10.5 | 2.4 | 1 | NA |
| 5 | + | 13.7 | 1.5 | 0.9 | 1.3 |
| 1 | + | 10.7 | 3.1 | 1.8 | 1 |
| 0.5 | + | 8.7 | 1.5 | 0.9 | 0.8 |
| 0.1 | + | 12.7 | 5 | 2.9 | 1.3 |
| 0.05 | + | 9.7 | 1.5 | 0.9 | 0.9 |
| Positive Control (2AA) | + | 132.8 | 10.9 | 4.5 | 12.6 |
| Vehicle | - | 15.5 | 3.7 | 1.5 | NA |
| 5 | - | 21.3 | 2.3 | 1.3 | 1.4 |
| 1 | - | 13 | 2.6 | 1.5 | 0.8 |
| 0.5 | - | 15.3 | 4.5 | 2.6 | 1 |
| 0.1 | - | 9 | 3.5 | 2 | 0.6 |
| 0.05 | - | 16 | 4.4 | 2.5 | 1 |
| Positive Control (NaN3) | - | 606.8 | 45.6 | 18.6 | 39.1 |
| Main Assay | |||||
| S. typh. TA-98 | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 25.3 | 5 | 2.1 | NA |
| 5 | + | 26 | 5.3 | 3.1 | 1 |
| 1 | + | 26.3 | 4 | 2.3 | 1 |
| 0.5 | + | 26.7 | 7.8 | 4.5 | 1.1 |
| 0.1 | + | 24.7 | 1.5 | 0.9 | 1 |
| 0.05 | + | 19.7 | 6.4 | 3.7 | 0.8 |
| Positive Control (2AA) | + | 2230 | 180.3 | 73.6 | 88.9 |
| Vehicle | - | 19 | 4.8 | 1.9 | NA |
| 5 | - | 15.3 | 2.1 | 1.2 | 0.8 |
| 1 | - | 19.7 | 3.1 | 1.8 | 1 |
| 0.5 | - | 24.3 | 1.2 | 0.7 | 1.3 |
| 0.1 | - | 18.7 | 2.1 | 1.2 | 1 |
| 0.05 | - | 22.7 | 8.1 | 4.7 | 1.2 |
| Positive Control (DM) | - | 980.8 | 105.7 | 43.2 | 51.6 |
| Main Assay | |||||
| S. typh. TA-100 | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 98.7 | 8 | 3.3 | NA |
| 5 | + | 80.7 | 9.8 | 5.7 | 0.8 |
| 1 | + | 78 | 7.2 | 4.2 | 0.8 |
| 0.5 | + | 87.7 | 7.6 | 4.4 | 0.9 |
| 0.1 | + | 82 | 16.6 | 9.6 | 0.8 |
| 0.05 | + | 94 | 6.6 | 3.8 | 1 |
| Positive Control (2AA) | + | 1889.2 | 193.4 | 79 | 19.1 |
| Vehicle | - | 69.8 | 10.8 | 4.4 | NA |
| 5 | - | 88 | 4.6 | 2.6 | 1.3 |
| 1 | - | 68.7 | 16.2 | 9.4 | 1 |
| 0.5 | - | 73 | 7.9 | 4.6 | 1.1 |
| 0.1 | - | 76.7 | 12.1 | 7 | 1.1 |
| 0.05 | - | 73.3 | 2.3 | 1.3 | 1.1 |
| Positive Control (NaN3) | - | 441.3 | 39.2 | 16 | 6.3 |
| Independent Repeat Assay | |||||
| E. coli | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 103.3 | 6 | 2.5 | NA |
| 5 | + | 91.3 | 16.6 | 9.6 | 0.9 |
| 1 | + | 101 | 19.1 | 11 | 1 |
| 0.5 | + | 96.7 | 3.1 | 1.8 | 0.9 |
| 0.1 | + | 98.7 | 4 | 2.3 | 1 |
| 0.05 | + | 101.3 | 6.4 | 3.7 | 1 |
| Positive Control (2AA) | + | 304.3 | 18.9 | 7.7 | 2.9 |
| Vehicle | - | 108.8 | 6 | 2.5 | NA |
| 5 | - | 99 | 9.8 | 5.7 | 0.9 |
| 1 | - | 109.7 | 10.2 | 5.9 | 1 |
| 0.5 | - | 116 | 10.1 | 5.9 | 1.1 |
| 0.1 | - | 114.3 | 8 | 4.6 | 1.1 |
| 0.05 | - | 109 | 7.9 | 4.6 | 1 |
| Positive Control (MMS) | - | 703.7 | 43.6 | 17.8 | 6.5 |
| Repeat Assay | |||||
| E. coli | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | - | 39.8 | 6.2 | 2.5 | NA |
| 5 | - | 29.3 | 3.5 | 2 | 0.7 |
| 1 | - | 39 | 6.1 | 3.5 | 1 |
| 0.5 | - | 39 | 5.3 | 3.1 | 1 |
| 0.1 | - | 32 | 8.7 | 5 | 0.8 |
| 0.05 | - | 44.7 | 4 | 2.3 | 1.1 |
| Positive Control (2AA) | - | 217.3 | 26.7 | 10.9 | 5.5 |
| Independent Repeat Assay | |||||
| S. typh. TA-97a | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 158.3 | 15.1 | 6.2 | NA |
| 5 | + | 180 | 23.4 | 13.5 | 1.1 |
| 1 | + | 158.3 | 23.3 | 13.4 | 1 |
| 0.5 | + | 162.7 | 5.5 | 3.2 | 1 |
| 0.1 | + | 158.7 | 20 | 11.6 | 1 |
| 0.05 | + | 148 | 8.9 | 5.1 | 0.9 |
| Positive Control (2AA) | + | 808.2 | 43.3 | 17.7 | 5.1 |
| Vehicle | - | 97.5 | 6.6 | 2.7 | NA |
| 5 | - | 126.3 | 17 | 9.8 | 1.3 |
| 1 | - | 109 | 14.7 | 8.5 | 1.1 |
| 0.5 | - | 103 | 18.2 | 10.5 | 1.1 |
| 0.1 | - | 78.3 | 5.1 | 3 | 0.8 |
| 0.05 | - | 88.7 | 1.5 | 0.9 | 0.9 |
| Positive Control (ICR191) | - | 737.2 | 58.4 | 23.8 | 7.6 |
| Independent Repeat Assay | |||||
| S. typh. TA-1535 | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 9.5 | 2.1 | 0.8 | NA |
| 5 | + | 12 | 3 | 1.7 | 1.3 |
| 1 | + | 14.3 | 2.1 | 1.2 | 1.5 |
| 0.5 | + | 12.7 | 1.2 | 0.7 | 1.3 |
| 0.1 | + | 11 | 4.4 | 2.5 | 1.2 |
| 0.05 | + | 9 | 2.6 | 1.5 | 0.9 |
| Positive Control (2AA) | + | 170.5 | 12.7 | 5.2 | 17.9 |
| Vehicle | - | 11.8 | 3.3 | 1.5 | NA |
| 5 | - | 16 | 2.6 | 1.5 | 1.4 |
| 1 | - | 15.3 | 2.1 | 1.2 | 1.3 |
| 0.5 | - | 9.3 | 2.1 | 1.2 | 0.8 |
| 0.1 | - | 12.3 | 4.2 | 2.4 | 1 |
| 0.05 | - | 12.3 | 2.1 | 1.2 | 1 |
| Positive Control (NaN3) | - | 626.8 | 24.9 | 10.2 | 53.1 |
| Independent Repeat Assay | |||||
| S. typh. TA-98 | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 25.7 | 3.4 | 1.5 | NA |
| 5 | + | 22.7 | 6.1 | 3.5 | 0.9 |
| 1 | + | 21.7 | 3.5 | 2 | 0.8 |
| 0.5 | + | 23.3 | 2.5 | 1.5 | 0.9 |
| 0.1 | + | 23 | 4.6 | 2.6 | 0.9 |
| 0.05 | + | 20.3 | 1.5 | 0.9 | 0.8 |
| Positive Control (2AA) | + | 2895.3 | 377.6 | 154.1 | 112.7 |
| Vehicle | - | 16.7 | 5.6 | 2.3 | NA |
| 5 | - | 15.7 | 1.2 | 0.7 | 0.9 |
| 1 | - | 12.7 | 1.5 | 0.9 | 0.8 |
| 0.5 | - | 11.3 | 5.5 | 3.2 | 0.7 |
| 0.1 | - | 15.7 | 2.1 | 1.2 | 0.9 |
| 0.05 | - | 19.7 | 4 | 2.3 | 1.2 |
| Positive Control (DM) | - | 1198.7 | 109.3 | 44.6 | 71.8 |
| Independent Repeat Assay | |||||
| S. typh. TA-100 | |||||
| Treatment (uL/plate) | S9 | Mean | Standard Deviation | Standard Error of Mean | Fold Increase Over Vehicle |
| Vehicle | + | 102.2 | 10.9 | 4.4 | NA |
| 5 | + | 86 | 8.5 | 4.9 | 0.8 |
| 1 | + | 91 | 9.8 | 5.7 | 0.9 |
| 0.5 | + | 88.3 | 6.8 | 3.9 | 0.9 |
| 0.1 | + | 91.7 | 6.7 | 3.8 | 0.9 |
| 0.05 | + | 102.3 | 11.5 | 6.7 | 1 |
| Positive Control (2AA) | + | 1802.2 | 97.8 | 39.9 | 17.6 |
| Vehicle | - | 74 | 7.7 | 3.1 | NA |
| 5 | - | 86.7 | 17.6 | 10.1 | 1.2 |
| 1 | - | 88.7 | 4 | 2.3 | 1.2 |
| 0.5 | - | 83.3 | 7.6 | 4.4 | 1.1 |
| 0.1 | - | 79.7 | 7.5 | 4.3 | 1.1 |
| 0.05 | - | 76.7 | 18.6 | 10.7 | 1 |
| Positive Control (NaN3) | - | 519.3 | 33.3 | 13.6 | 7 |
Applicant's summary and conclusion
- Conclusions:
- The test substance does not have mutagenic potential.
- Executive summary:
The mutagenic potential of the test substance was determined in an OECD 471 Bacterial Reverse Mutation Assay. Concentrations of 0.05, 0.1, 0.5, 1, and 5 uL/plate were tested. The tester strains: E. coli WP2 uvrA, S. typh. TA-97a, S. typh. TA-1535, S. typh. TA-98, and S. typh TA-100 were tested with and without metabolic activation. No genotoxicity was seen in the main assay. Therefore, the assay was repeated, and no genotoxicity was seen in the repeat assay. The test substance therefore does not have mutagenic potential.
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