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EC number: 245-589-7 | CAS number: 23328-87-2
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 May 2017 - 24 Jan 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21 Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesleitstelle Bayern, Bayerisches Landesamt für Gesundheit, Schwabach, Deutschland
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-heptadecyl-1H-imidazole
- EC Number:
- 245-589-7
- EC Name:
- 2-heptadecyl-1H-imidazole
- Cas Number:
- 23328-87-2
- Molecular formula:
- C20H38N2
- IUPAC Name:
- 2-heptadecyl-1H-imidazole
1
Method
- Target gene:
- his operon for (for S. typhimurium strains)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital/β-naphthoflavone
- Test concentrations with justification for top dose:
- Pre-experiment for Toxicity: 0.316, 1.00, 3.16, 10.0, 31.6, 100, 250 and 500 µg/plate with and without metabolic activation for TA 98 and TA 100
Experiment 1: 3.16, 10.0, 31.6, 100, 250 and 500 µg/plate with and without metabolic activation
Experiment 2: 1.58, 5.00, 15.8, 50.0, 158 and 500 µg/plate with and without metabolic activation
The test substance concentrations used in the main experiment were chosen according to the results of the pre-experiment. Due to the limited solubility of the test item 500 µg/plate was selected as the maximum concentration. The concentration range covered two logarithmic decades.
As the results of the pre-experiment were in accordance with the criteria described above, these were reported as a part of the main experiment 1. - Vehicle / solvent:
- - Vehicle/solvent used: tetrahydrofuran, VWR (Lot No. 17C051199)
- Justification for choice of solvent/vehicle: A solubility test with several solvents (distilled water, DMSO, ethanol, acetone and tetrahydrofuran) was performed. No solution and no homogenous suspension could be obtained with these solvents at the recommended maximum stock solution of 50 mg/mL. According to a Eurofins Study #174109 a stock solution of 5 mg/mL in tetrahydrofuran was used. The test item was freshly prepared as solution in tetrahydrofuran and diluted prior to treatment. The solvent was compatible with the survival of the bacteria and the S9 activity. A correction factor of 1.07 was applied to consider the purity of the test item.
Controls
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- tetrahydrofuran
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (4-NOPD), 2-aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar, plate incorporation test (pre-experiment and main experiment 1 and 2)
DURATION
- Exposure duration: at least 48 - 72 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of spontaneous revertants down to a mutation factor of approximately ≤ 0.5 or a clearing of the bacterial background lawn - Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98 and TA 100 the number of reversions is at least twice as high
- if in tester strain TA 102 the number of reversions is at least 1.5-fold higher
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - Statistics:
- Mean values and standard deviations were calculated.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative 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
- 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 102
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In two independent experiments several concentrations of the test substance were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. Due to the limited solubility of the test substance 500 µg/plate was selected as the maximum concentration. Since no homogenous suspension could be obtained with the tested solvents at the recommended maximum stock solution of 50 mg/mL, the suspension was diluted up to solubility of the test substance at a stock solution of 5 mg/mL. As at higher concentrations a part of the test substance retains at the bottom of the test tube and could not poured over the surface of a minimal agar plate, it was not possible to perform the test up to precipitating concentrations. No precipitation of the test substance was observed in any tester strain used in experiment 1 and 2 (with and without metabolic activation).
RANGE-FINDING/SCREENING STUDIES: Only strain TA 98 and TA 100 were tested in the pre-experiment.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No toxic effects of the test substance was observed in any strain.
Any other information on results incl. tables
Table 2: Results pre-experiment
Test Substance |
Dose (µg/plate) |
TA 98 |
TA 100 |
||
Mutation Factor [toxicity]* |
Mutation Factor [toxicity]* |
||||
without S9 |
with S9 |
without S9 |
with S9 |
||
Solvent Control (Tetrahydrofuran) |
|
1.0 |
1.0 |
1.0 |
1.0 |
4-NOPD |
10.0 |
8.0 |
- |
- |
- |
NaN3 |
10.0 |
- |
- |
11.1 |
- |
2-AA |
2.50 |
- |
61.1 |
- |
10.7 |
Test Substance |
0.316 |
1.0 |
1.1 |
0.9 |
0.8 |
1.00 |
0.9 |
1.1 |
1.1 |
0.7 |
|
3.16 |
0.8 |
0.9 |
1.0 |
0.8 |
|
10.0 |
0.9 |
1.1 |
1.1 |
1.0 |
|
31.6 |
0.8 |
0.9 |
1.2 |
0.8 |
|
100 |
0.8 |
1.2 |
1.1 |
0.8 |
|
250 |
0.8 |
1.2 |
1.0 |
1.1 |
|
500 |
1.1 |
1.0 |
1.0 |
1.2 |
*toxicity parameter: B = Background lawn reduced; N = No background lawn
Table 3: Results experiment 1
|
EXPERIMENT 1 (Revertant colonies per plate ± SD) |
|||||
|
S9-Mix |
Without
|
||||
|
Test Substance (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Distilled water |
|
40 ± 2.3 |
89 ± 12.6 |
23 ± 1.2 |
17 ± 3.2 |
252 ± 14.0 |
Tetrahydrofuran |
|
39 ± 8.1 |
75 ± 8.9 |
20 ± 2.1 |
20 ± 2.5 |
243 ± 8.0 |
Test Substance |
3.16 |
30 ± 3.1 |
74 ± 12.7 |
21 ± 4.0 |
19 ± 2.0 |
212 ± 5.1 |
10.0 |
37 ± 7.5 |
83 ± 14.8 |
22 ± 2.3 |
19 ± 1.5 |
205 ± 30.0 |
|
31.6 |
32 ± 2.1 |
94 ± 8.5 |
21 ± 2.5 |
19 ± 2.6 |
195 ± 24.4 |
|
100 |
30 ± 6.7 |
85 ± 3.1 |
19 ± 2.6 |
18 ± 3.6 |
201 ± 6.0 |
|
250 |
32 ± 5.5 |
74 ± 11.0 |
18 ± 2.9 |
20 ± 3.5 |
255 ± 33.3 |
|
500 |
42 ± 5.0 |
76 ± 10.8 |
21 ± 3.1 |
19 ± 4.2 |
292 ± 25.5 |
|
4-NOPD |
10 (TA 98)/40 (TA 1537) |
313 ± 9.2 |
- |
- |
119 ± 10.0 |
- |
NaN3 |
10 |
- |
834 ± 131.6 |
945 ± 44.8 |
- |
- |
MMS |
1 |
|
|
|
|
2394 ± 318.7 |
|
S9-Mix |
With
|
||||
|
Test Substance (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Distilled water |
- |
39 ± 5.1 |
96 ± 9.1 |
19 ± 1.0 |
24 ± 4.6 |
241 ± 20.0 |
Tetrahydrofuran |
- |
37 ± 7.5 |
97 ±7.5 |
17 ± 2.6 |
25 ± 2.0 |
215 ± 7.2 |
Test Substance |
31.6 |
33 ± 3.2 |
81 ± 17.1 |
14 ± 2.5 |
23 ± 2.0 |
451 ± 310.3 |
100 |
39 ± 0.6 |
93 ± 26.1 |
18 ± 2.0 |
22 ± 1.5 |
265 ± 29.5 |
|
316 |
32 ± 6.0 |
77 ± 22.9 |
17 ± 1.2 |
20 ± 1.5 |
226 ± 13.0 |
|
1000 |
43 ± 6.0 |
82 ± 7.4 |
18 ± 3.0 |
23 ± 1.0 |
227 ± 12.1 |
|
2500 |
43 ± 5.2 |
107 ± 8.3 |
20 ± 5.5 |
21 ± 3.2 |
209 ± 18.2 |
|
5000 |
35 ± 9.0 |
121 ± 11.7 |
17 ± 3.5 |
20 ± 3.5 |
233 ± 35.7 |
|
2-AA |
2.5/ 10 (only TA 102) |
2242 ± 463.6 |
1039 ± 339.6 |
155 ± 6.7 |
208 ± 9.5 |
470 ± 229.4 |
|
SD = Standard Deviation |
Table 4: Results experiment 2
|
EXPERIMENT 2 (Revertant colonies per plate ± SD) |
|||||
|
S9-Mix |
Without
|
||||
|
Test Substance (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Distilled water |
|
26 ± 4.5 |
126 ± 3.5 |
25 ± 1.0 |
13 ± 2.1 |
288 ± 28.0 |
Tetrahydrofuran |
|
34 ± 4.0 |
99 ± 17.2 |
25 ± 3.5 |
15 ± 1.0 |
391 ± 4.2 |
Test Substance |
1.58 |
31 ± 4.2 |
90 ± 8.4 |
37 ± 2.1 |
13 ± 2.6 |
314 ± 14.9 |
5.00 |
29 ± 4.9 |
93 ± 10.1 |
34 ± 2.1 |
14 ± 2.6 |
347 ± 10.8 |
|
15.8 |
25 ± 3.6 |
99 ± 9.1 |
27 ± 3.6 |
15 ± 2.5 |
358 ± 35.4 |
|
50.0 |
29 ± 4.4 |
94 ± 8.5 |
31 ± 3.1 |
18 ± 2.3 |
403 ± 10.8 |
|
158 |
25 ± 3.8 |
94 ± 6.2 |
31 ± 3.8 |
13 ± 1.0 |
390 ± 18.5 |
|
500 |
29 ± 7.9 |
84 ± 5.5 |
30 ± 4.4 |
13 ± 1.0 |
406 ± 2.1 |
|
4-NOPD |
10 (TA 98)/40 (TA 1537) |
255 ± 67.3 |
- |
- |
212 ± 7.8 |
- |
NaN3 |
10 |
- |
901 ± 20.1 |
891 ± 46.5 |
- |
- |
MMS |
1 |
|
|
|
|
2152 ± 31.5 |
|
S9-Mix |
With
|
||||
|
Test Substance (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
Distilled water |
- |
27 ± 4.6 |
117 ± 19.4 |
29 ± 2.6 |
25 ± 5.0 |
406 ± 18.7 |
Tetrahydrofuran |
- |
25 ± 2.3 |
92 ± 8.7 |
26 ± 1.5 |
22 ± 2.1 |
380 ± 16.3 |
Test Substance |
1.58 |
32 ± 4.0 |
105 ± 12.9 |
23 ± 2.5 |
25 ± 2.5 |
338 ± 23.0 |
5.00 |
28 ± 8.7 |
108 ± 20.7 |
26 ± 2.5 |
25 ± 2.1 |
361 ± 2.6 |
|
15.8 |
32 ± 8.1 |
100 ± 8.1 |
25 ± 1.0 |
24 ± 4.0 |
376 ± 9.3 |
|
50.0 |
25 ± 4.4 |
115 ± 4.6 |
23 ± 4.5 |
23 ± 2.0 |
371 ± 12.5 |
|
158 |
26 ± 4.0 |
91 ± 10.2 |
24 ± 7.2 |
22 ± 2.1 |
391 ± 6.1 |
|
500 |
37 ± 2.6 |
106 ± 18.8 |
22 ± 7.0 |
23 ± 1.5 |
361 ± 12.5 |
|
2-AA |
2.5/ 10 (only TA 102) |
1407 ± 67.6 |
847 ± 151.9 |
247 ± 5.3 |
283 ± 10.0 |
1119 ± 59.9 |
|
SD = Standard Deviation |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test the test substance was not mutagenic in any of the five strains (TA 98, TA 100, TA 1535, TA 1537 and TA 102) tested with and without metabolic activation up to 500 µg/plate.
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