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EC number: 263-179-6 | CAS number: 61791-46-6
- 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:
- 09 April - 08 June, 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:
- 21 July 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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- EC Number:
- 263-179-6
- EC Name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- Cas Number:
- 61791-46-6
- Molecular formula:
- n.a
- IUPAC Name:
- Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides
- Test material form:
- semi-solid (amorphous): gel
Constituent 1
Method
- Target gene:
- his
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:
- Sodium phenobarbitone and β-naphthoflavone induced rat liver S9 homogenate (S9 Mix)
- Test concentrations with justification for top dose:
- 0.001, 0.003, 0.01, 0.03 and 0.1 mg/plate
Based on the results of initial cytotoxicity test, the concentrations for testing in the mutation test were selected. - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: The test item was found miscible in DMSO at 50 mg/mL.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with S9 mix, TA98, TA100,TA102,TA1535,TA1537, 4 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9 mix, TA98, 2 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix, TA100,TA1535, 1 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9 mix, TA102, 0.5 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix, TA1535, 50 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 30 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth, viable count
- Evaluation criteria:
- There should be a dose related increase over the range tested and/or a reproducible increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing doses of the test item either in the presence or absence of the metabolic activation system.
The test will be judged positive if the increase in mean revertants at the peak of the dose response is equal to or greater than 2 times the mean vehicle control value in Salmonella typhimurium strains TA98, TA100 and TA102 or equal to or greater than 3 times the mean vehicle control value in tester strains TA1535 and TA1537. An equivocal response is a biologically relevant increase in a revertant count that partially meets the criteria for evaluation as positive. This could be a dose responsive increase that does not achieve the respective threshold cited above or a non dose responsive increase that is equal to or greater than the respective threshold cited. A response will be evaluated as negative, if it is neither positive nor equivocal. - Statistics:
- None
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:
- cytotoxicity
- Remarks:
- 0.1 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 0.1 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 0.1 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Remarks:
- 0.1 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 0.1 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Based on the results of precipitation test, the concentrations of 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4 and 5 mg/plate were selected for the initial cytotoxicity test. The Salmonella typhimurium TA100 tester strain was exposed to vehicle control and the above indicated concentrations of the test item in the presence and absence of metabolic activation system. Incubation with the test item resulted in cytotoxicity, indicated by a thinning and disappearance of the bacterial background lawn.
Based on the results of initial cytotoxicity test, the tester strain Salmonella typhimurium TA100 was exposed with test item in the presence and absence of metabolic activation system at concentrations of 0.4, 0.2, 0.1, 0.05, 0.025, 0.0125, 0.00625 and 0.003125 mg/plate. The test item resulted in cytotoxicity at 0.1, 0.2 and 0.4 mg/plate.
Based on the results of initial cytotoxicity test, concentrations of 0.001, 0.003, 0.01, 0.03 and 0.1 mg/plate was selected for testing in the mutation test.
HISTORICAL CONTROL DATA
see "Any other information on materials and methods"
Any other information on results incl. tables
Table 1: Historical Data
Plate Incorporation Method
Metabolic Activation |
With Metabolic Activation |
|
Without Metabolic Activation |
|||||||||
Tester strain |
Salmonella typhimurium |
Salmonella typhimurium |
||||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||
Vehicle Control (DMSO) |
Mean |
21.3 |
103.4 |
21.2 |
9.2 |
260.3 |
21.2 |
102.8 |
21.2 |
9.4 |
261.8 |
|
±SD |
3.2 |
5.5 |
2.2 |
1.8 |
5.2 |
2.7 |
4.7 |
2.3 |
1.9 |
5.2 |
||
Min |
16 |
96 |
13 |
6 |
251 |
15 |
91 |
15 |
7 |
254 |
||
Max |
40 |
130 |
26 |
14 |
272 |
32 |
126 |
27 |
15 |
274 |
||
Positive Control |
Mean |
401.7 |
383.6 |
140.1 |
119.2 |
606.2 |
396.6 |
379.7 |
141.1 |
120.1 |
613.4 |
|
±SD |
23.4 |
16.9 |
8.0 |
6.6 |
27.6 |
27.4 |
18.3 |
9.9 |
7.3 |
22.6 |
||
Min |
256 |
246 |
118 |
100 |
510 |
290 |
270 |
110 |
98 |
589 |
||
Max |
440 |
419 |
182 |
149 |
670 |
430 |
446 |
190 |
158 |
694 |
||
Preincubation Method |
||||||||||||
Metabolic Activation |
With Metabolic Activation |
|
Without Metabolic Activation |
|||||||||
Tester strain |
Salmonella typhimurium |
Salmonella typhimurium |
||||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||
Vehicle Control (DMSO) |
Mean |
21.2 |
102.9 |
20.9 |
9.4 |
262.3 |
20.9 |
102.1 |
21.1 |
9.6 |
263.8 |
|
±SD |
2.8 |
4.6 |
2.2 |
2.0 |
4.6 |
2.8 |
4.3 |
2.3 |
2.6 |
5.5 |
||
Min |
16 |
89 |
14 |
4 |
256 |
15 |
88 |
16 |
6 |
251 |
||
Max |
32 |
128 |
28 |
17 |
275 |
32 |
129 |
28 |
23 |
275 |
||
Positive Control |
Mean |
402.5 |
383.9 |
140.6 |
118.6 |
606.5 |
398.3 |
381.3 |
141.3 |
119.5 |
616.0 |
|
±SD |
18.5 |
16.1 |
9.3 |
6.3 |
26.7 |
24.5 |
16.2 |
11.0 |
6.4 |
25.9 |
||
Min |
290 |
293 |
103 |
99 |
508 |
281 |
312 |
110 |
97 |
590 |
||
Max |
429 |
425 |
187 |
151 |
670 |
428 |
450 |
200 |
173 |
699 |
Min: Minimum no. of colonies, Max: Maximum no. of colonies, SD: Standard Deviation
Table 2: Summary of the Colony Counts of Revertants, Plate incorporation Method
Treatment |
Test Concentration (mg/plate) |
No. of Revertants (Mean of 3 Plates) |
|||||||||||
With S9 |
|
Without S9 |
|||||||||||
Salmonella typhimurium |
Salmonella typhimurium |
||||||||||||
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
||||
Vehicle Control |
100 µL of Dimethyl Sulphoxide |
Mean |
27.7 |
112.0 |
267.0 |
22.0 |
10.0 |
28.0 |
106.7 |
264.0 |
21.7 |
9.0 |
|
±SD |
3.1 |
4.0 |
5.6 |
2.6 |
2.0 |
2.0 |
9.1 |
4.6 |
2.5 |
2.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Humectol LYS Mod |
0.001 |
Mean |
22.3 |
113.0 |
263.7 |
22.0 |
11.0 |
22.7 |
111.3 |
262.3 |
20.3 |
10.0 |
|
±SD |
4.9 |
7.2 |
7.1 |
2.6 |
2.0 |
1.5 |
4.2 |
4.2 |
2.1 |
2.0 |
|||
Fold Increase |
0.8 |
1.0 |
1.0 |
1.0 |
1.1 |
0.8 |
1.0 |
1.0 |
0.9 |
1.1 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.003 |
Mean |
23.0 |
107.0 |
261.0 |
20.7 |
9.3 |
21.0 |
101.7 |
256.0 |
20.3 |
9.7 |
||
±SD |
3.6 |
5.6 |
9.2 |
1.5 |
2.1 |
1.0 |
7.0 |
5.3 |
2.5 |
2.1 |
|||
Fold Increase |
0.8 |
1.0 |
1.0 |
0.9 |
0.9 |
0.8 |
1.0 |
1.0 |
0.9 |
1.1 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.01 |
Mean |
22.0 |
107.0 |
264.0 |
20.7 |
9.7 |
21.3 |
105.0 |
258.3 |
22.0 |
9.3 |
||
±SD |
3.6 |
7.0 |
4.6 |
3.1 |
2.1 |
2.5 |
6.0 |
10.4 |
3.0 |
2.1 |
|||
Fold Increase |
0.8 |
1.0 |
1.0 |
0.9 |
1.0 |
0.8 |
1.0 |
1.0 |
1.0 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.03 |
Mean |
19.7 |
108.0 |
254.0 |
18.7 |
7.0 |
19.3 |
101.3 |
251.3 |
18.3 |
7.0 |
||
±SD |
1.5 |
9.5 |
5.0 |
1.5 |
1.0 |
2.5 |
8.0 |
5.5 |
2.5 |
1.7 |
|||
Fold Increase |
0.7 |
1.0 |
1.0 |
0.8 |
0.7 |
0.7 |
1.0 |
1.0 |
0.8 |
0.8 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.1 |
Mean |
13.7 |
60.3 |
223.3 |
13.0 |
4.0 |
13.0 |
60.0 |
219.3 |
12.0 |
3.7 |
||
±SD |
1.5 |
4.5 |
7.8 |
1.0 |
1.0 |
2.0 |
2.6 |
7.0 |
1.0 |
0.6 |
|||
Fold Increase |
0.5 |
0.5 |
0.8 |
0.6 |
0.4 |
0.5 |
0.6 |
0.8 |
0.6 |
0.4 |
|||
Lawn Intensity |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
|||
Positive Control |
100 µL of respective Positive Control |
Mean |
357.3 |
400.0 |
607.3 |
139.3 |
108.3 |
351.0 |
401.0 |
606.7 |
128.3 |
102.0 |
|
±SD |
10.7 |
5.6 |
11.9 |
8.5 |
11.7 |
9.5 |
7.5 |
5.9 |
12.0 |
11.0 |
|||
Fold Increase |
12.9 |
3.6 |
2.3 |
6.3 |
10.8 |
12.5 |
3.8 |
2.3 |
5.9 |
11.3 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Positive controls: with S9: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 = 4 µg/plate of 2-Aminoanthracene without S9: TA98: 2 µg/plate of 2-Nitrofluorene TA100 and TA1535: 1 µg/plate of Sodium azide. TA102: 0.5 µg/plate of Mitomycin C TA1537: 50 µg/plate of 9-Aminoacridine |
Table 3: Summary of the Colony Counts of Revertants, Preincubation Method
Treatment |
Test Concentration (mg/plate) |
No. of Revertants (Mean of 3 Plates) |
|||||||||||
With S9 |
|
Without S9 |
|||||||||||
Salmonella typhimurium |
Salmonella typhimurium |
||||||||||||
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
||||
Vehicle Control |
100 µL of Dimethyl Sulphoxide |
Mean |
27.3 |
112.7 |
262.3 |
23.0 |
10.0 |
24.7 |
108.0 |
263.3 |
22.0 |
9.3 |
|
±SD |
3.1 |
5.7 |
7.1 |
1.0 |
2.6 |
4.2 |
8.2 |
4.5 |
2.6 |
2.1 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Humectol LYS Mod |
0.001 |
Mean |
21.7 |
112.0 |
263.3 |
21.7 |
9.3 |
22.0 |
106.7 |
258.7 |
20.3 |
9.3 |
|
±SD |
3.5 |
3.6 |
7.1 |
3.1 |
3.1 |
2.6 |
6.1 |
9.0 |
2.5 |
1.5 |
|||
Fold Increase |
0.8 |
1.0 |
1.0 |
0.9 |
0.9 |
0.9 |
1.0 |
1.0 |
0.9 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.003 |
Mean |
23.3 |
106.0 |
260.3 |
20.7 |
9.3 |
20.3 |
104.3 |
262.3 |
20.3 |
9.7 |
||
±SD |
2.5 |
4.6 |
9.3 |
2.5 |
1.5 |
1.5 |
5.0 |
9.3 |
1.5 |
2.5 |
|||
Fold Increase |
0.9 |
0.9 |
1.0 |
0.9 |
0.9 |
0.8 |
1.0 |
1.0 |
0.9 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.01 |
Mean |
23.3 |
102.3 |
263.3 |
20.3 |
9.7 |
20.7 |
107.0 |
263.7 |
21.7 |
9.3 |
||
±SD |
4.0 |
7.8 |
9.1 |
4.9 |
2.5 |
3.1 |
5.6 |
7.0 |
2.1 |
1.5 |
|||
Fold Increase |
0.9 |
0.9 |
1.0 |
0.9 |
1.0 |
0.8 |
1.0 |
1.0 |
1.0 |
1.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.03 |
Mean |
21.0 |
99.0 |
260.3 |
18.3 |
7.0 |
18.7 |
88.7 |
266.0 |
18.0 |
6.7 |
||
±SD |
2.0 |
3.6 |
8.6 |
2.5 |
1.0 |
1.5 |
2.5 |
7.5 |
1.0 |
1.5 |
|||
Fold Increase |
0.8 |
0.9 |
1.0 |
0.8 |
0.7 |
0.8 |
0.8 |
1.0 |
0.8 |
0.7 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.1 |
Mean |
13.7 |
59.3 |
210.0 |
13.0 |
4.0 |
14.0 |
58.3 |
210.3 |
13.0 |
3.7 |
||
±SD |
2.1 |
4.2 |
8.2 |
2.0 |
1.0 |
1.0 |
3.1 |
5.5 |
1.0 |
0.6 |
|||
Fold Increase |
0.5 |
0.5 |
0.8 |
0.6 |
0.4 |
0.6 |
0.5 |
0.8 |
0.6 |
0.4 |
|||
Lawn Intensity |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
|||
Positive Control |
100 µL of respective Positive Control |
Mean |
356.7 |
405.0 |
595.0 |
128.3 |
110.3 |
347.7 |
402.0 |
596.7 |
113.0 |
109.3 |
|
±SD |
4.9 |
5.6 |
16.7 |
7.5 |
18.2 |
7.5 |
5.6 |
12.7 |
9.6 |
9.5 |
|||
Fold Increase |
13.0 |
3.6 |
2.3 |
5.6 |
11.0 |
14.1 |
3.7 |
2.3 |
5.1 |
11.7 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Positive controls: with S9: Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 = 4 µg/plate of 2-Aminoanthracene without S9: TA98: 2 µg/plate of 2-Nitrofluorene TA100 and TA1535: 1 µg/plate of Sodium azide. TA102: 0.5 µg/plate of Mitomycin C TA1537: 50 µg/plate of 9-Aminoacridine |
Applicant's summary and conclusion
- Conclusions:
- In an in vitro bacterial reverse mutation assay (Ames) according to OECD guideline 471, the test item did not show a mutagenic potential.
- Executive summary:
The test item was evaluated for mutagenicity in an in vitro bacterial reverse mutation assay according to OECD 471. The test item was found soluble in dimethyl sulphoxide at a concentration of 50 mg/mL. In an preliminary cytotoxicity test, the tester strain Salmonella typhimurium TA100 was exposed to vehicle control, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4 and 5 mg/plate. Precipitation of the test item was observed at 3, 4 and 5 mg/plate. Cytotoxicity was observed at all the tested concentration in an initial cytotoxicity test. To further assess the cytotoxicity and to select the appropriate test concentration for the mutation assay a follow up cytotoxicity test was performed at 0.4, 0.2, 0.1, 0.05, 0.025, 0.0125, 0.00625 and 0.003125 mg/plate. Cytotoxicity was observed, indicated by a thinning of the bacterial background lawn at 0.1, 0.2 and 0.4 mg/plate. Based on these results, concentrations of 0.001, 0.003, 0.01, 0.03 and 0.1 mg/plate were selected for the main mutation test.
The following Salmonella typhimurium tester strains were tested: TA98, TA100, TA 102, TA1535, and TA1537. The test item was tested at the concentrations of 0.001, 0.003, 0.01, 0.03 and 0.1 mg/plate for plate incorporation method and for preincubation method using dimethyl sulphoxide as vehicle based on the results of solubility, precipitation and initial cytotoxicity test. The study was conducted with and without metabolic activation (S9 fraction). The S9 fraction was prepared from sodium phenobarbitone and β-naphthoflavone induced rat liver. Vehicle control and appropriate positive controls (2-nitrofluorene, sodium azide, 9-Aminoacridine and Mitomycin C, for trials “without metabolic activation” and 2-Aminoanthracene for trials “with metabolic activation”) were tested simultaneously. Two trials were carried out for this study in triplicate. Trial I was carried out as plate incorporation test and trial II as pre incubation test.
Based on the experimental results obtained, the mean numbers of revertant colonies at the tested concentrations were comparable to those of the vehicle control in both the trials in the presence and absence of metabolic activation. There was no increase in number of revertant colonies at any of the tested concentrations in both the trials. The mean numbers of revertant colonies of vehicle control values were comparable to negative control values. The number of revertant colonies in the positive controls resulted in 2.3 to 14.1 fold increase under identical conditions. The positive controls and solvent controls were valid.
Based on the results of the study, it is concluded that the test item is “non-mutagenic” in the Bacterial Reverse Mutation Test up to the highest tested concentration of 0.1 mg/plate under the described test conditions.
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