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EC number: 242-362-4 | CAS number: 18479-58-8
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- Aquatic toxicity
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- Short-term toxicity to fish
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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to generally valid and/or internationally accepted testing guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,6-dimethyloct-7-en-2-ol
- EC Number:
- 242-362-4
- EC Name:
- 2,6-dimethyloct-7-en-2-ol
- Cas Number:
- 18479-58-8
- Molecular formula:
- C10H20O
- IUPAC Name:
- 2,6-dimethyloct-7-en-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Dihydromyrcenol
- Physical state: Clear, colorless slightly viscous liquid
- Analytical purity: 99.2% (COA)
- Purity test date: 29 October 2010
- Lot/batch No.: 9SFD04
- Expiration date of the lot/batch: 27 October 2011
- Storage condition of test material: Room temperature in the dark under nitrogen
- Other: Information relating to the identity, purity and stability of the test material was the responsibility of the Sponsor
Constituent 1
Method
- Target gene:
- Salmonella typhimurium:
TA 1535, TA 100: hisG46
TA 1537: hisC3076
TA 98: hisD3052
Escherichia coli (WP2uvrA/pKM101):
contains ochre mutation; deficient in DNA repair system 9uvrA); contains the pKM101 plasmid
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test
0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 microg/plate
Experiment 1 (Range-finding)
15, 50, 150, 500, 1500 and 5000 microg/plate
Mutation Test (Main Test) - with preincubation
TA100 (with/without S9), TA1535 and TA1537 (without S9) and E. coli (without S9): 1.5, 5, 15, 50, 150, 500 and 1500 microg/plate
TA98 (with/without S9), TA1535 and TA1537 (with S9) and E. coli (with S9): 15, 50, 150, 500, 1500 and 5000 microg/plate - Vehicle / solvent:
- dimethyl sulphoxide
The test material was immiscible in sterile distilled water at 50 mg/mL but was fully miscible in dimethyl sulphoxide at the same concentration.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Pos. Control for TA98 at 5 microg/plate (+S9)
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2AA)
- Remarks:
- Pos. Control for TA100 at 1 microg/plate (+S9); TA1535 and TA1537, 2 microg/plate (+S9); and E. coli WP2uvrA- at 10 microg/plate (+S9)
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Pos. Control for E. coli WP2uvrA- at 2 microg/plate (-S9); TA100 at 3 microg/plate (-S9); TA1535 at 5 microg/plate (-S9)
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Pos. Control for TA1537 at 80 microg/plate (-S9)
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Pos. Control for TA98 at 0.2 microg/plate (-S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
A standard plate incorporation method was employed.
Preliminary Toxicity Test:
In order to select appropriate dose levels for use in the main test, a preliminary test were conducted in the presence or absence of S9. Ten dose levels and controls were tested up to and including 5,000 microg/plate at approximately half-log intervals. The assay was conducted by mixing 0.1 ml the bacterial culture (TA100 or WP2uvrA-), and 0.1 ml of the vehicle or test chemical mixture, 0.5 mL of S9-mix or phosphate buffer and 2.0 ml of molten agar supplemented with trace histidine or tryptophan and overlaying onto sterile plates of Vogel-Bonner Minimal agar (30 mL/plate). After approximately 48 hours incubation at 37 deg C, the plates were assessed for numbers of revertant colonies using a Domino colony counter and examined for effects on the growth of the bacterial background lawn.
Experiment 1 (Range-finding Test):
Six concentrations of the test material were assayed with or without S9-mix against each tester strain using the above described direct plate incorporation method. An additional dose level and expanded dose range were selected in order to achieve both four non-toxic doses and the toxic limit of the test material.
Experiment 2 (Main Test):
A second experiment was performed with fresh bacterial cultures, test material and control solutions. The dose ranges selected were based on the range-finding test and an aborted main test (data not shown). Preincubation was employed. Thus, measured aliquots (0.1 mL) of each bacterial culture were dispensed into sets of test tubes followed by 0.5 mL of S9-mix or phosphate buffer and 0.1 mL of vehicle or test material formulation and incubated for 20 minutes at 37 deg C with shaking at approximately 130 rpm prior to addition of 2 mL of molten trace histidine or tryptophan supplemented top agar. The contents of the tubes were mixed and poured onto the surface of Vogel-Bonner Minimal agar plates. This procedure was repeated for each bacterial strain either with or without S9.
NUMBER OF REPLICATIONS:
3 replicates/strain
DETERMINATION OF CYTOTOXICITY
Any toxic effects of the test substance would be detected by a substantial reduction in revertant colony counts or by the absence of a complete bacterial lawn. - Evaluation criteria:
- Acceptance Criteria:
The following criteria must be met for acceptance:
- All tester strain cultures must exhibit a characteristic number of spontaneous revertants per plate in vehicle and untreated controls.
- The appropriate characteristics of each tester strain must be confirmed, eg rfa cell-wall mutation and pKM101 plasmid R-factor.
- All tester strain cultures should be in the range of 1 to 9.9 x 10^9 bacteria per mL.
- Each mean positive control value should be at least 2x the respective vehicle control value for each strain, thus demonstrating both the intrinsic sensitivity of the tester strains and the integrity of the S9-mix
- The test should include a minimum of four non-toxic dose levels.
Evaluation Criteria:
A dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain either with or without metabolic activation. Biological relevance of the response is to be considered first, as recommended by the UKEMS sub-committee on Guidelines for Mutagenicity Testing (1989). Statistical methods can be used as an aid to evaluation but may not be the only determining factor for a positive response.
A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Statistics:
- Mean values with standard deviations were 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- Please refer to Tables 1 to 5 for details of results.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Preliminary Toxicity Test
The test material was toxic at 5000 microg/plate to tester strains TA100 and WP2uvrA-. The results are summarized in Table 1.
Table 1: Numbers of revertant colonies in the preliminary toxicity test
With (+) or without (-) S9-mix | Strain | Dose (mg/plate) | ||||||||||
0 | 0.15 | 0.5 | 1.5 | 5 | 15 | 50 | 150 | 500 | 1500 | 5000 | ||
- | TA100 | 93 | 100 | 120 | 101 | 123 | 133 | 132 | 106 | 128 | 152 | 113* |
+ | TA100 | 62 | 107 | 77 | 82 | 81 | 88 | 94 | 84 | 84 | 74 | 0* |
- | WP2uvrA- | 18 | 15 | 16 | 18 | 22 | 33 | 24 | 14 | 19 | 20 | 17* |
+ | WP2uvrA- | 28 | 32 | 22 | 27 | 22 | 20 | 24 | 25 | 25 | 31 | 15* |
* Partial absence of bacterial background lawn
Table 2: Range-finding test without metabolic activation
Revertant colony counts (mean 3 replicates) | |||||
Addition (mg) | TA100 | TA1535 | WP2uvrA- | TA98 | TA1537 |
0 | 101 | 24 | 18 | 17 | 11 |
15 | 81 | 30 | 19 | 15 | 10 |
50 | 86 | 28 | 19 | 19 | 10 |
150 | 91 | 23 | 17 | 20 | 9 |
500 | 99 | 27 | 18 | 18 | 11 |
1500 | 92 | 27 | 20 | 14 | 10 |
5000 | 82* | 15* | 13 | 12* | 2* |
ENNG (3) | 421 | ||||
ENNG (5) | 907 | ||||
ENNG (2) | 596 | ||||
4NQO (0.2) | 167 | ||||
9AA (80) | 354 |
* Partial absence of background lawn in all replicate plates.
Abreviations: ENNG, N-ethyl-Nā-nitro-N-nitrosoguanidine; 9AA, 2-aminoacridine; BP, benzo(a)pyrene; 2AA, 2-aminoanthracene; 4NQO, 4-nitroquinoline-1-oxide
Table 3: Range-finding test with metabolic activation
Revertant colony counts (mean 3 replicates) | |||||
Addition (mg) | TA100 | TA1535 | WP2uvrA- | TA98 | TA1537 |
0 | 88 | 14 | 22 | 19 | 14 |
15 | 90 | 15 | 22 | 21 | 14 |
50 | 87 | 14 | 21 | 15 | 14 |
150 | 88 | 10 | 19 | 21 | 10 |
500 | 74 | 11 | 23 | 19 | 10 |
1500 | 84 | 9 | 17 | 16 | 9 |
5000 | 72* | 2* | 17 | 12* | 3* |
2AA (1) | 760 | ||||
2AA (2) | 212 | 195 | |||
2AA (10) | 244 | ||||
BP (5) | 119 |
* Partial absence of background lawn in all replicate plates.
Table 4: Main Test without metabolic activation
Revertant colony counts (mean 3 replicates) | |||||
Addition (mg) | TA100 | TA1535 | WP2uvrA- | TA98 | TA1537 |
0 | 106 | 28 | 26 | 11 | 12 |
1.5 | 107 | 24 | 26 | N/T | 14 |
5 | 103 | 27 | 17 | N/T | 12 |
15 | 108 | 29 | 20 | 15 | 9 |
50 | 100 | 25 | 21 | 10 | 8 |
150 | 107* | 28 | 26 | 15 | 9 |
500 | 76* | 27* | 25 | 10 | 8* |
1500 | 0* | 0* | 0* | 0* | 0* |
5000 | N/T | N/T | N/T | 0* | N/T |
ENNG (3) | 406 | ||||
ENNG (5) | 291 | ||||
ENNG (2) | 498 | ||||
4NQO (0.2) | 100 | ||||
9AA (80) | 937 |
* Partial absence of background lawn in all replicate plates.
N/T - not tested at this dose level.
Table 5: Main Test with metabolic activation
Revertant colony counts (mean 3 replicates) | |||||
Addition (mg) | TA100 | TA1535 | WP2uvrA- | TA98 | TA1537 |
0 | 114 | 10 | 18 | 19 | 9 |
1.5 | 102 | N/T | N/T | N/T | N/T |
5 | 115 | N/T | N/T | N/T | N/T |
15 | 90 | 11 | 17 | 22 | 11 |
50 | 102 | 11 | 21 | 25 | 8 |
150 | 103 | 14 | 19 | 20 | 10 |
500 | 95* | 11 | 15 | 18 | 7 |
1500 | 0* | 0* | 0* | 0* | 0* |
5000 | N/T | 0* | 0* | 0* | 0* |
2AA (1) | 813 | ||||
2AA (2) | 230 | 199 | |||
2AA (10) | 212 | ||||
BP (5) | 248 |
* Partial absence of background lawn in all replicate plates.
N/T - not tested at this dose level.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The test material was considered non-mutagenic under the conditions of this test. - Executive summary:
In the first experiment, the test material caused a visible reduction in the growth f the bacterial background lawns of all the Salmonella stains at 5000 microg/plate in both the presence and absence of S9. No toxic response to Escherichia coli strain WP2uvrA- was noted. In the second experiment (with pre-incubation) the test material reduced the bacterial background lawns of all the tester strains in both the presence and absence of S9. The sensitivity of the various stains varied with the presence or absence of S9 and the strain involved; therefore, the test material was tested up to the maximum recommended dose level. No test material precipitate was observed on the plates at any of the doses tested either with or without S9.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9 -mix and the sensitivity of the bacterial strains.
The test material was considered to be non-mutagenic under the conditions of this test.
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