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EC number: 203-951-1 | CAS number: 112-25-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study according to OECD Guideline 471
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-hexyloxyethanol
- EC Number:
- 203-951-1
- EC Name:
- 2-hexyloxyethanol
- Cas Number:
- 112-25-4
- Molecular formula:
- C6H13OCH2CH2OH
- IUPAC Name:
- 2-hexyloxyethanol
- Details on test material:
- - Name of test material: n-Hexylglycol
- Physical state: liquid, colorless, clear
- Analytical purity: > 99.2%
- Lot/batch No.: Tank: B711 (December 1st, 2007)
- Expiration date of the lot/batch: May 31th, 2008
- Storage condition of test material: Room temperature (N2 conditions)
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:
- S9 mix
- Test concentrations with justification for top dose:
- 20; 100; 500; 2 500 and 5 000 μg/plate (Standard Plate Test)
312.5; 625; 1 250; 2 500 and 5 000 μg/plate (Preincubation Test) - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of vehicle: Due to the limited solubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- without tester strains
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: With S9 mix: 2-aminoanthracene (2.5 µg/plate in DMSO). Without S9 mix: N-methyl-N'-nitro-N-nitrosoguanidine (5 µg/plate in DMSO; TA 1535 & TA 100), 4-nitro-o-phenylenediamine (10 µg/plate in DMSO; TA 98), 9-aminoacridine (100 µg/plate in DMSO; TA 1537)
- Remarks:
- S. typhimurium strains
- Untreated negative controls:
- yes
- Remarks:
- without tester strains
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: With S9 mix: 2-aminoanthracene (60 µg/plate in DMSO). Without S9 mix: 4-nitroquinoline-N-oxide (5 µg/plate in DMSO)
- Remarks:
- E. coli WP2 uvrA
- Details on test system and experimental conditions:
- STANDARD PLATE TEST:
The experimental procedure of the standard plate test (plate incorporation method) is based on the method of Ames et al. (Mut. Res. 31:347-364, 1975; Mut. Res. 113:173-215, 1983).
- Salmonella typhimurium:
Test tubes containing 2-mL portions of soft agar (overlay agar), which consists of 100 mL agar (0.8% [w/v] agar + 0.6% [w/v] NaCl) and 10 mL amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM histidine + 0.5 mM biotin) are kept in a water bath at about 42-45°C, and the remaining components are added in the following order:
0.1 mL test solution or vehicle (negative control)
0.1 mL fresh bacterial culture
0.5 mL S9 mix (with metabolic activation)
or
0.5 mL phosphate buffer (without metabolic activation)
After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within approx. 30 seconds.
Composition of the minimal glucose agar:
980 mL purified water
20 mL Vogel-Bonner E medium
15 g Difco bacto agar
20 g D-glucose, monohydrate.
After incubation at 37°C for 48–72 h in the dark, the bacterial colonies (his+ revertants) are counted.
- Escherichia coli:
Test tubes containing 2-mL portions of soft agar (overlay agar), which consists of 100 mL agar (0.8% [w/v] agar + 0.6% [w/v] NaCl) and 10 mL amino acid solution (minimal amino acid solution for the determination of mutants: 0.5 mM tryptophan) are kept in a water bath at about 42-45°C, and the remaining components are added in the following order:
0.1 mL test solution or vehicle (negative control)
0.1 mL fresh bacterial culture
0.5 mL S9 mix (with metabolic activation)
or
0.5 mL phosphate buffer (without metabolic activation)
After mixing, the samples are poured onto minimal agar plates within approx. 30 sec. The composition of the minimal agar (SA1 selective agar) is based on the description of Green MHL and Muriel WJ (Mut. Res. 38:3-32, 1976), with the exception of solution E (tryptophan solution), which has previously been added to the soft agar:
300 mL solution B (agar)
100 mL solution A (saline solution)
8 mL solution C (glucose solution)
10 mL solution D (casein solution)
After incubation at 37°C for 48-72 h in the dark, the bacterial colonies (trp+ revertants) are counted.
PREINCUBATION TEST:
The experimental procedure is based on the method described by Yahagi et al. (Mut. Res. 48:121-130, 1977) and Matsushima et al. (In: Norpoth, K.H. and R.C. Garner, Short-Term Test Systems for Detecting Carcinogens. Springer Verlag Berlin, Heidelberg, New York (1980)).
0.1 mL test solution or vehicle, 0.1 mL bacterial suspension and 0.5 mL S9 mix (with metabolic activation) or phosphate buffer (without metabolic activation) are incubated at 37°C for the duration of about 20 min using a shaker. Subsequently, 2 mL of soft agar is added and, after mixing, the samples are poured onto the agar plates within approx. 30 sec.
After incubation at 37°C for 48-72 h in the dark, the bacterial colonies are counted.
TITER DETERMINATION:
The titer was determined only in the experimental parts with S9 mix both for the negative controls (vehicle only) and for the two highest doses in all experiments.
In the standard plate test, 0.1 mL of the overnight cultures is diluted to 10E-6 in each case. Test tubes containing 2-mL portions of soft agar containing maximal amino acid solution (5 mM tryptophan or 5 mM histidine + 0.5 mM biotin) are kept in a water bath at about 42-45°C, and the remaining components are added in the following order:
0.1 mL vehicle (without and with test substance)
0.1 mL fresh bacterial culture (dilution: 10E-6)
0.5 mL S9 mix
In the preincubation test, 0.1 mL of the overnight cultures is diluted to 10E-6 in each case. 0.1 mL vehicle (with and without test substance), 0.1 mL bacterial suspension and 0.5 mL S9 mix are incubated at 37°C for about 20 min using a shaker. Subsequently, 2 mL of soft agar containing maximal amino acid solution for titer determination (5 mM tryptophan or 5 mM histidine + 0.5 mM biotin) is added.
After mixing, the samples are poured onto the agar plates within approx. 30 sec. After incubation at 37°C for 48-72 h in the dark, the bacterial colonies are counted. - Evaluation criteria:
- Evaluation criteria are mutagenicity of the test substance, bacterial titer, toxicity and solubilty of the test substance.
Acceptance criteria are as follows:
- The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
- The sterility controls revealed no indication of bacterial contamination.
- The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
- The titer of viable bacteria was > 10E8/mL.
Assessment criteria are as follows:
- The test chemical is considered positive in this assay if a dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system, is observed.
- A test substance is generally considered non-mutagenic in this test if the number of revertants for all tester strains are within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.
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
- Remarks:
- > 2500 μg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- > 2500 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test substance precipitation was found with and without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA:
The results of the negative as well as the positive controls performed in parallel corroborated the validity of this study, since the values fulfilled the acceptance criteria of this study. In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data or above.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A bacteriotoxic effect (decrease in the number of his+ revertants, reduction in the titer) was occasionally observed in the standard plate test depending on the strain and test conditions from about 2 500 μg/plate onward. In the preincubation assay bacteriotoxicity (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed from about 2 500 μg/plate onward. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results of the Standard Plate Test:
Dose/plate (µg) |
Without S9 mix |
With S9 mix (1:9) |
||
Mean |
SD |
Mean |
SD |
|
Salmonella typhimurium TA 1535 |
||||
0 (DMSO) |
16 |
1 |
15 |
4 |
20 |
16 |
5 |
12 |
2 |
100 |
13 |
3 |
14 |
4 |
500 |
14 |
1 |
12 |
2 |
2500 |
13 |
4 |
11 |
4 |
5000 |
8 |
1 |
4 |
1 |
MNNG 5.0 µg |
559 |
28 |
||
2-AA 2.5 µg |
163 |
20 |
||
Salmonella typhimurium TA 100 |
||||
0 (DMSO) |
111 |
3 |
112 |
7 |
20 |
96 |
7 |
115 |
8 |
100 |
110 |
3 |
109 |
13 |
500 |
98 |
11 |
117 |
6 |
2500 |
91 |
10 |
116 |
7 |
5000 |
71 |
10 |
82 |
3 |
MNNG 5.0 µg |
586 |
58 |
||
2-AA 2.5 µg |
913 |
141 |
||
Salmonella typhimurium TA 1537 |
||||
0 (DMSO) |
9 |
3 |
9 |
2 |
20 |
9 |
2 |
11 |
1 |
100 |
8 |
3 |
10 |
1 |
500 |
8 |
2 |
8 |
2 |
2500 |
8 |
2 |
6 |
2 |
5000 |
3 |
2 |
4 |
2 |
AAC 100.0 µg |
467 |
25 |
||
2-AA 2.5 µg |
154 |
15 |
||
Salmonella typhimurium TA 98 |
||||
0 (DMSO) |
29 |
6 |
36 |
9 |
20 |
25 |
7 |
36 |
8 |
100 |
29 |
3 |
57 |
14 |
500 |
29 |
7 |
41 |
3 |
2500 |
26 |
2 |
28 |
4 |
5000 |
15 |
6 |
27 |
7 |
NOPD 10.0 µg |
433 |
41 |
||
2-AA 2.5 µg |
914 |
60 |
||
Escherichia coli WP2 uvrA |
||||
0 (DMSO) |
35 |
3 |
38 |
6 |
20 |
33 |
9 |
53 |
4 |
100 |
35 |
4 |
46 |
5 |
500 |
39 |
12 |
44 |
12 |
2500 |
33 |
2 |
49 |
9 |
5000 |
29 |
7 |
32 |
11 |
4-NQO 5.0 µg |
792 |
39 |
||
2-AA 60 µg |
277 |
7 |
Table 2: Results of the Preincubation Test:
Dose/plate (µg) |
Without S9 mix |
With S9 mix (1:9) |
||
Mean |
SD |
Mean |
SD |
|
Salmonella typhimurium TA 1535 |
||||
0 (DMSO) |
16 |
1 |
15 |
3 |
312.5 |
18 |
7 |
15 |
4 |
625 |
14 |
1 |
14 |
1 |
1250 |
14 |
3 |
14 |
2 |
2500 |
11 |
2 |
11 |
2 |
5000 |
0B |
0B |
0B |
0B |
MNNG 5.0 µg |
539 |
18 |
||
2-AA 2.5 µg |
129 |
18 |
||
Salmonella typhimurium TA 100 |
||||
0 (DMSO) |
103 |
13 |
96 |
6 |
312.5 |
99 |
13 |
102 |
7 |
625 |
98 |
8 |
92 |
9 |
1250 |
104 |
9 |
106 |
6 |
2500 |
78 |
12 |
78 |
7 |
5000 |
0B |
0B |
0B |
0B |
MNNG 5.0 µg |
723 |
48 |
||
2-AA 2.5 µg |
768 |
28 |
||
Salmonella typhimurium TA 1537 |
||||
0 (DMSO) |
8 |
2 |
9 |
3 |
312.5 |
8 |
2 |
5 |
2 |
625 |
8 |
3 |
6 |
3 |
1250 |
7 |
2 |
7 |
3 |
2500 |
7 |
1 |
5 |
1 |
5000 |
0B |
0B |
0B |
0B |
AAC 100.0 µg |
487 |
57 |
||
2-AA 2.5 µg |
130 |
18 |
||
Salmonella typhimurium TA 98 |
||||
0 (DMSO) |
29 |
5 |
33 |
6 |
312.5 |
26 |
5 |
33 |
3 |
625 |
28 |
5 |
34 |
3 |
1250 |
27 |
6 |
34 |
4 |
2500 |
23 |
4 |
31 |
6 |
5000 |
0B |
0B |
0B |
0B |
NOPD 10.0 µg |
581 |
57 |
||
2-AA 2.5 µg |
583 |
34 |
||
Escherichia coli WP2 uvrA |
||||
0 (DMSO) |
34 |
2 |
42 |
3 |
312.5 |
45 |
10 |
39 |
11 |
625 |
41 |
2 |
38 |
7 |
1250 |
38 |
5 |
37 |
10 |
2500 |
38 |
3 |
29 |
3 |
5000 |
0B |
0B |
0B |
0B |
4-NQO 5.0 µg |
587 |
39 |
||
2-AA 60 µg |
254 |
34 |
B: Reduced background growth
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
The test substance is not mutagenic in the bacterial reverse mutation test in the absence and the presence of metabolic activation. - Executive summary:
The study was performed according to OECD Guideline 471 under GLP conditions.
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. The used strains were S. typhimurium TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvr. The applied dose ranges were 20-5000 μg/plate for the standard plate test (SPT) and 312.5 -5000 μg/plate for the preincubation test (PIT), respectively. SPT and PIT were performed both with and without metabolic activation (induced rat liver S9 mix). No precipitation of the test substance was found. A bacteriotoxic effect was observed depending on the strain and test conditions from about 2500 μg/plate onward. An increase in the number of his+ (S. typhimurium) or trp+ (E. coli) revertants was not observed in the SPT or in the PIT either without S9 mix or after the addition of a metabolizing system.
Conclusion: The test substance is not mutagenic in the bacterial reverse mutation test in the absence and the presence of metabolic activation.
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