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EC number: 254-074-6 | CAS number: 38668-46-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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 - 11 Dec 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted July 21, 2017
- 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:
- 6-[2-(2-methyl-1H-imidazol-1-yl)ethyl]-1,3,5-triazine-2,4-diamine
- EC Number:
- 254-074-6
- EC Name:
- 6-[2-(2-methyl-1H-imidazol-1-yl)ethyl]-1,3,5-triazine-2,4-diamine
- Cas Number:
- 38668-46-1
- Molecular formula:
- C9H13N7
- IUPAC Name:
- 6-[2-(2-methyl-1H-imidazol-1-yl)ethyl]-1,3,5-triazine-2,4-diamine
Constituent 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: 3.16, 10, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate with and without metabolic activation for TA 98 and TA 100
Main experiment: 31.6, 100, 316, 1000, 2500 and 5000 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. - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 acitivity.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- 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) (Pre-experiment and main experiment 1) and pre-incubation test (experiment 2)
DURATION
- Preincubation period: 1 h
- 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 count by the mean values of the solvent control (the exact and not rounded values are used for calculation)
A test substance is considered mutagenic if:
- a clear 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 metabloic activation.
A biologically relevant increase is describes as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- 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: No precipitation of the test substance occurred up to the highest investigated dose 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 1: Pre-Experiment
Substance |
Dose (µg/plate) |
TA98 Mutation Factor (toxicity*) |
TA 100 Mutation Factor (toxicity*) |
||
|
without S9 |
with S9 |
without S9 |
with S9 |
|
Vehicle Control, DMSO |
1.0 |
1.0 |
1.0 |
1.0 |
|
4-NOPD |
10.0 |
16.1 |
- |
- |
- |
NaN3 |
10.0 |
- |
- |
15.2 |
- |
2-AA |
2.50 |
- |
38.2 |
- |
17.2 |
Test Substance |
3.16 |
1.1 |
0.7 |
1.2 |
0.9 |
10.0 |
0.9 |
0.8 |
1.2 |
1.2 |
|
31.6 |
1.1 |
0.9 |
1.0 |
1.1 |
|
100 |
0.8 |
0.7 |
1.0 |
1.2 |
|
316 |
0.9 |
0.8 |
1.0 |
1.0 |
|
1000 |
0.9 |
0.7 |
1.0 |
1.0 |
|
2500 |
0.9 |
0.6 |
1.3 |
1.1 |
|
5000 |
0.8 |
0.7 |
1.4 |
1.1 |
* toxicity parameter: B = Background lawn reduced, N = No background lawn
Table 2: Experiment 1 (Plate-incorporation Test)
|
EXPERIMENT 1 (Revertant colonies per plate ± SD) |
|||||
|
S9-Mix |
Without
|
||||
|
Test item (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
A.dest |
|
25 ± 3.6 |
76 ± 13.6 |
12 ± 2.1 |
12 ± 2.0 |
296 ± 15.4 |
DMSO |
|
30 ± 6.4 |
59 ± 5.0 |
11 ± 2.6 |
12 ± 3.1 |
309 ± 8.2 |
Test Substance |
31.6 |
33 ± 2.5 |
61 ± 10.6 |
12 ± 3.0 |
13 ± 2.6 |
278 ± 6.5 |
100 |
25 ± 3.1 |
57 ± 7.5 |
12 ± 3.6 |
11 ± 1.2 |
256 ± 28.5 |
|
316 |
26 ± 2.9 |
57 ± 8.4 |
11 ± 3.5 |
12 ± 1.0 |
275 ± 1.5 |
|
1000 |
26 ± 4.6 |
58 ± 9.2 |
11 ± 4.4 |
13 ± 2.1 |
271 ± 11.5 |
|
2500 |
25 ± 4.0 |
77 ± 25.1 |
11 ± 1.7 |
16 ± 1.0 |
239 ± 7.2 |
|
5000 |
22 ± 1.5 |
83 ± 12.7 |
10 ± 2.0 |
13 ± 3.2 |
253 ± 16.5 |
|
4-NOPD |
10 (TA 98)/40 (TA 1537) |
478 ± 62.1 |
- |
- |
111 ± 2.6 |
- |
NaN3 |
10 |
- |
892 ± 59.0 |
1114 ± 79.0 |
- |
- |
MMS |
1 |
|
|
|
|
1503 ±309.3 |
|
S9-Mix |
With
|
||||
|
Test item (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
A.dest |
- |
30 ± 2.3 |
70 ± 1.5 |
8 ± 1.0 |
14 ± 06 |
294 ± 19.6 |
DMSO |
- |
33 ± 2.0 |
68 ±13.2 |
8 ± 1.5 |
13 ± 0.6 |
309 ± 8.4 |
|
31.6 |
29 ± 2.5 |
75 ± 16.1 |
10 ± 2.1 |
14 ± 0.6 |
292 ± 25.8 |
|
100 |
23 ± 4.0 |
81 ± 6.6 |
11 ± 3.1 |
16 ± 1.0 |
278 ± 23.6 |
|
316 |
25 ± 7.6 |
65 ± 2.5 |
8 ± 0.6 |
14 ± 0.6 |
321 ± 39.3 |
|
1000 |
24 ± 8.2 |
68 ± 7.6 |
10 ± 2.1 |
13 ± 1.5 |
327 ± 24.2 |
|
2500 |
19 ± 2.3 |
72 ± 6.2 |
8 ± 2.5 |
13 ± 2.6 |
256 ± 70.7 |
|
5000 |
24 ± 1.2 |
74 ± 8.2 |
9 ± 2.3 |
14 ± 1.0 |
284 ± 44.3 |
2-AA |
2.5/ 10 (only TA 102) |
1260 ± 338.4 |
1175 ± 817.3 |
84 ± 32.4 |
227 ± 16.1 |
897 ± 74.1 |
|
NC = Negative/Vehicle Control PC = Respective positive control substances (for details see method description) SD = Standard Deviation |
Table 3: Experiment 2 (Pre-incubation Test)
|
EXPERIMENT 2 (Revertant colonies per plate ± SD) |
|||||
|
S9-Mix |
Without
|
||||
|
Test item (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
A.dest |
|
25 ± 4.2 |
79 ± 17.6 |
13 ± 2.5 |
20 ± 1.5 |
267 ± 43.5 |
DMSO |
|
23 ± 3.2 |
72 ± 2.3.0 |
15 ± 4.2 |
18 ± 1.2 |
325 ± 55.9 |
Test Substance |
31.6 |
24 ± 3.2 |
94 ± 10.3 |
12 ± 4.1 |
17 ± 3.2 |
267 ± 35.8 |
100 |
35 ± 2.9 |
79 ± 9.0 |
14 ± 2.1 |
17 ± 1.5 |
218 ± 2.6 |
|
316 |
22 ± 2.1 |
80 ± 6.9 |
17 ± 1.2. |
18 ± 0.6 |
224 ± 13.5 |
|
1000 |
35 ± 4.0 |
87 ± 6.8 |
12 ± 2.0 |
19 ± 2.0 |
259 ± 22.3 |
|
2500 |
24 ± 0.6 |
70 ± 6.1 |
13 ± 3.0 |
15 ± 1.0 |
244 ± 24.0 |
|
5000 |
27 ± 7.2 |
69 ± 67.7 |
12 ± 2.1 |
16 ± 2.0 |
260 ± 14.6 |
|
4-NOPD |
10 (TA 98)/40 (TA 1537) |
307 ± 34.6 |
- |
- |
157 ± 40.0 |
- |
NaN3 |
10 |
- |
852 ± 67.7 |
1168 ± 32.4 |
- |
- |
MMS |
1 |
- |
- |
- |
- |
2496 ± 102.4 |
|
S9-Mix |
With
|
||||
|
Test item (µg/plate) |
TA98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
A.dest |
- |
30 ± 5.5 |
83 ± 11.9 |
12 ± 3.2 |
17 ± 1.5 |
316 ± 21.5 |
DMSO |
- |
27 ± 3.6 |
69 ±15.0 |
14 ± 2.0 |
19 ± 2.1 |
258 ± 17.3 |
|
31.6 |
34 ± 6.7 |
67 ± 13.9 |
15 ± 3.1 |
21 ± 3.1 |
280 ± 23.0 |
|
100 |
32 ± 9.2 |
81 ± 11.7 |
15 ± 1.2 |
17 ± 1.5 |
279 ± 14.0 |
|
316 |
34 ± 6.7 |
72 ± 8.1 |
16 ± 2.0 |
19 ± 1.5 |
287 ± 28.3 |
|
1000 |
22 ± 3.8 |
77 ± 6.1 |
13 ± 2.6 |
18 ± 3.2 |
265 ± 21.5 |
|
2500 |
32 ± 4.0 |
62 ± 5.6 |
15 ± 1.2 |
17 ± 1.0 |
266 ± 16.4 |
|
5000 |
28 ± 8.1 |
59 ± 5.2 |
13 ± 3.1 |
20 ± 2.1 |
277 ± 14.0 |
2-AA |
2.5/ 10 (only TA 102) |
1189 ± 216.9 |
958 ± 93.5 |
172 ± 20.2 |
149 ± 23.4 |
683 ± 15.0 |
|
NC = Negative/Vehicle Control PC = Respective positive control substances SD = Standard Deviation |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test the 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 5000 µg/plate.
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