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EC number: 223-470-0 | CAS number: 3913-02-8
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:
- 2006-09-20 until 2006-10-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-butyloctan-1-ol
- EC Number:
- 223-470-0
- EC Name:
- 2-butyloctan-1-ol
- Cas Number:
- 3913-02-8
- Molecular formula:
- C12H26O
- IUPAC Name:
- 2-butyloctan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Isofol 12
- Substance type: not mentioned
- Physical state: liquid
- Lot/batch No.: A68263
- Expiration date of the lot/batch: 2010-03-29
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: at room temperature
Constituent 1
Method
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
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 mix of Phenobarbital/ß-Naphthoflavone induced rats
- Test concentrations with justification for top dose:
- Experiment I: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate; Experiment II: 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not mentioned
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-Nitro-o-phenylene-diamine (10 µg 4-NOPD/plate in TA 98 and 50 µg 4-NOPD/plate in TA 1537
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- Untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2.5 µg 2-AA/plate, TA 1535, TA 1537, TA 98 and TA 100), 10 µg 2-AA/plate in WP2 uvrA
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: The study was performed in two independent tests in the plate incorporation test (Experiment I) and the pre-incubation test (Experiment II)
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 per concentration
DETERMINATION OF CYTOTOXICITY
- Method: not mentioned
OTHER EXAMINATIONS:
- Other: Determination of the frequency of induced or spontaneous reversion to histidine independence with negative controls (H2O), solvent controls (DMSO), test substance concentrations and positive controls; determination of the titers of overnight cultures
OTHER: none - Evaluation criteria:
- The test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed. A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment. A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
- Statistics:
- no statistics performed
Results and discussion
Test resultsopen allclose all
- 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
- Untreated negative 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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not measured
- Effects of osmolality: not applicable
- Evaporation from medium: not applicable
- Water solubility: not mentioned
- Precipitation: no
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: not performed
COMPARISON WITH HISTORICAL CONTROL DATA: not performed
ADDITIONAL INFORMATION ON CYTOTOXICITY: none
Any other information on results incl. tables
Table #1: Pre-Experiment/Experiment I: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 98] |
[Strain TA 100] |
[Strain TA 1535] |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
29 ± 1 |
44 ± 4 |
no |
164 ± 24 |
195 ± 32 |
no |
24 ± 4 |
33 ± 11 |
no |
3 |
35 ± 5 |
29 ± 6 |
no |
186 ± 12 |
186 ± 24 |
no |
29 ± 3 |
32 ± 9 |
no |
10 |
34 ± 7 |
41 ± 10 |
no |
150 ± 10 |
191 ± 10 |
no |
27 ± 5 |
30 ± 7 |
no |
33 |
30 ± 8 |
40 ± 5 |
no |
129 ± 25 |
207 ± 31 |
no |
24 ± 13 |
26 ± 2 |
no |
100 |
26 ± 1 |
31 ± 2 |
no |
128 ± 15 |
191 ± 13 |
no |
22 ± 2 |
24 ± 8 |
no |
333 |
20 ± 3 |
31 ± 7 |
no |
140 ± 16 |
145 ± 11 |
no |
24 ± 6 |
19 ± 4 |
no |
1000 |
22 ± 6 |
31 ± 1 |
no |
131 ± 17 |
110 ± 7 |
no |
27 ± 7 |
18 ± 4 |
no |
| 2500 | 21 ± 6 | 5 ± 2 R | no | 129 ± 20 | 61 ± 6 R | no | 14 ± 5 | 21 ± 4 R | no |
| 5000 | 23 ± 4 | 15 ± 1 R | no | 82 ± 6 | 51 ± 3 R | no | 19 ± 2 | 23 ± 2 R | no |
| Positive Control | 489 ± 35 | 2581 ± 503 | no | 2170 ± 80 | 4310 ± 73 | no | 1460 ± 14 | 524 ± 28 | no |
*solvent control with DMSO; R = Reduced background growth
Table #2: Pre-Experiment/Experiment I: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1537] |
[WP2 uvrA] |
|||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
|
0* |
15 ± 2 |
16 ± 1 |
no |
57 ± 7 |
73 ± 4 |
no |
|
3 |
15 ± 2 |
16 ± 7 |
no |
53 ± 3 |
85 ± 19 |
no |
|
10 |
17 ± 3 |
24 ± 9 |
no |
58 ± 11 |
79 ± 5 |
no |
|
33 |
11 ± 5 |
21 ± 1 |
no |
55 ± 5 |
70 ± 3 |
no |
|
100 |
13 ± 3 |
14 ± 5 |
no |
56 ± 3 |
65 ± 2 |
no |
|
333 |
11 ± 1 |
18 ± 7 |
no |
75 ± 20 |
88 ± 14 |
no |
|
1000 |
7 ± 4 |
11 ± 3 |
no |
62 ± 9 |
85 ± 16 |
no |
|
| 2500 | 5 ± 3 | 5 ± 2 R | no | 48 ± 5 | 40 ± 17 R | no | |
| 5000 | 6 ± 1 | 0 ± 0 R | no | 54 ± 8 | 31 ± 7 R | no | |
| Positive Control | 103 ± 30 | 462 ± 3 | no | 1085 ± 102 | 251 ± 42 | no | |
*solvent control with DMSO; R = Reduced background growth
Table #3: Experiment II: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 98] |
[Strain TA 100] |
[Strain TA 1535] |
||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
35 ± 1 |
33 ± 7 |
no |
135 ± 2 |
157 ± 2 |
no |
16 ± 5 |
19 ± 4 |
no |
10 |
31 ± 3 |
38 ± 5 |
no |
121 ± 12 |
138 ± 5 |
no |
15 ± 1 |
16 ± 6 |
no |
33 |
31 ± 2 |
38 ± 3 |
no |
93 ± 5 |
147 ± 9 |
no |
9 ± 1 |
27 ± 4 |
no |
100 |
25 ± 4 |
28 ± 3 |
no |
101 ± 3 |
99 ± 10 |
no |
6 ± 2 |
17 ± 6 |
no |
333 |
21 ± 4 |
25 ± 9 |
no |
81 ± 17 |
98 ± 21 |
no |
13 ± 4 |
10 ± 2 |
no |
1000 |
10 ± 3 |
23 ± 7 |
no |
52 ± 11 |
64 ± 8 |
no |
17 ± 4 |
10 ± 2 |
no |
| 2500 | 12 ± 2 MR | 21 ± 4 MR | no | 42 ± 4 MR | 39 ± 4 MR | no | 12 ± 3 MR | 7 ± 2 MR | no |
| 5000 | 6 ± 3 MR | 11 ± 3 MR | no | 13 ± 8 MR | 16 ± 2 MR | no | 7 ± 3 MR | 5 ± 1 MR | no |
| Positive Control | 500 ± 35 | 1492 ± 100 | no | 1863 ± 59 | 2839 ± 96 | no | 1656 ± 61 | 284 ± 15 | no |
*solvent control with DMSO; M = Manual count; R = Reduced background growth
Table #4: Experiment II: Number of revertants per plate (mean of 3 plates)
|
[Strain TA 1537] |
[WP2 uvrA] |
|||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
|
0* |
10 ± 4 |
15 ± 2 |
no |
49 ± 12 |
53 ± 5 |
no |
|
10 |
7 ± 6 |
20 ± 4 |
no |
51 ± 4 |
60 ± 4 |
no |
|
33 |
10 ± 3 |
17 ± 4 |
no |
45 ± 4 |
49 ± 13 |
no |
|
100 |
17 ± 10 |
6 ± 0 |
no |
44 ± 4 |
55 ± 6 |
no |
|
333 |
12 ± 2 |
10 ± 2 |
no |
47 ± 4 |
49 ± 20 |
no |
|
1000 |
7 ± 2 |
9 ± 3 |
no |
51 ± 8 |
52 ± 11 |
no |
|
| 2500 | 6 ± 2 MR | 1 ± 1 MR | no | 35 ± 7 MR | 31 ± 3 MR | no | |
| 5000 | 2 ± 1 MR | 0 ± 0 MR | no | 28 ± 4 MR | 26 ± 6 MR | no | |
| Positive Control | 119 ± 13 | 319 ± 44 | no | 752 ± 55 | 208 ± 31 | no | |
*solvent control with DMSO; M = Manual Count; R = Reduced background growth
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study under the experimental conditions 2-butyloctan-1-ol does not induce gene mutations by base pair
changes or frameshifts in the genome and is therefore not mutagenic. - Executive summary:
Based on the results of this study under the experimental conditions 2-butyloctan-1-ol does not induce gene mutations by base pair
changes or frameshifts in the genome and is therefore not mutagenic.
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