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EC number: 918-105-3 | CAS number: -
- 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
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1-{6-[3,5-bis(6-isocyanatohexyl)-2,4,6-trioxo-1,3,5-triazinan-1-yl]hexyl}-3,3-bis[3-(trimethoxysilyl)propyl]urea
- EC Number:
- 918-105-3
- IUPAC Name:
- 1-{6-[3,5-bis(6-isocyanatohexyl)-2,4,6-trioxo-1,3,5-triazinan-1-yl]hexyl}-3,3-bis[3-(trimethoxysilyl)propyl]urea
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 17/0241-1, 294-296
- Expiration date of the lot/batch: 2020-05-09
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stable
- Stability under test conditions: yes
Method
- Target gene:
- histidine and tryptophan
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0, 33, 100, 333, 1000, 2500, 5000µg/plate (SPT)
0, 33, 100, 333, 1000, 2500, 5000µg/plate (PIT, TA1535, TA100, TA98, E.coli WP2 uvrA, TA 1537 with S9)
0, 10, 33, 100, 333, 1000, 2500 µg/plate (PIT, TA1537 without metabolic activation)
In agreement with the recommendations of current guidelines 5 mg/plate or 5 μL/plate were generally selected as maximum test dose at least in the 1st Experiment. However, this maximum dose was tested even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate or > 5 μL/plate might also be tested in repeat experiments for further clarification/substantiation. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the insolubility 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.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- other: 2-aminoanthracene, N-methyl-N'-nitro-N-nitrosoguanidine, 4-nitro-o-phenylenediamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48-72h at 37°C in the dark
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- Generally, the experiment was considered valid if the following criteria were met:
• 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.
• Fresh bacterial culture containing approximately 10^9 cells per mL were used.
The test substance was considered positive in this assay if the following criteria were met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the range of the historical negative control data 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
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the SPT with metabolic activation cytotoxicity was observed at 5000µg/plate and in the PIT without metabolic activation from 2500 and with metabolic activation from 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the SPT cytotoxicity was observed from 5000µg/plate without metabolic activation and in the PIT from 2500 without and from 5000 µg/plate with metabloic activation.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In the SPT cytotoxicity was observed from 1000µg/plate onwards and in the PIT from 33 µg/plate without and from 2500µg/plate onwards with metabolic activation.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Cytotoxicty was observed in the SPT at 5000µg/plate and in the PIT without metabolic activation from 333µg/plate onwards and with metabolic activation at 5000µg/plate.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Test substance precipitation of the test substance was found from about 1000 μg/plate onward with and without S9 mix in the standard plate test and without S9 mix in the preincubation test and from 2500 μg/plate with S9 mix in the preincubation test.
Any other information on results incl. tables
Standard Plate Test
E.coli WP2
Dose [µg/plate] | Without S9 [Revertants/plate] |
With S9 [Revertants/plate] | ||
Mean | Standard Deviation | Mean | Standard Deviation | |
DMSO | 24.0 | 1.7 | 22.0 | 3.6 |
33 |
23.7 |
4.5 |
27.7 |
4.7 |
100 |
26.3 |
2.5 |
22.7 |
8.0 |
333 |
20.0 |
1.0 |
26.3 |
8.5 |
1000 |
21.7 |
1.2 |
24.3 |
5.1 |
2500 |
25.3 |
3.5 |
20.0 |
5.2 |
5000 |
19.7 |
7.5 |
21.7 |
2.1 |
5.0 (4 -NQO) |
740.0 |
51.1 |
- |
- |
60 (2 -AA) |
- |
- |
86.7 |
11.6 |
TA 1535
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
9.3 |
3.2 |
8.7 |
3.1 |
33 |
12.0 |
0.0 |
10.0 |
4.4 |
100 |
10.7 |
1.5 |
10.3 |
1.2 |
333 |
9.0 |
4.4 |
7.7 |
0.6 |
1000 |
9.3 |
0.6 |
10.0 |
2.6 |
2500 |
7.3 |
0.6 |
8.7 |
1.5 |
5000 |
4.0 |
1.7 |
7.7 |
3.1 |
5.0 (MNNG) |
4514.0 |
374.4 |
- |
- |
2.5 (2 -AA) |
- |
- |
209.3 |
18.9 |
TA 100
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
106.7 |
14.4 |
120.3 |
21.5 |
33 |
111.7 |
16.9 |
122.0 |
19.1 |
100 |
89.7 |
5.1 |
117.0 |
11.5 |
333 |
87.7 |
6.5 |
116.7 |
4.2 |
1000 |
95.7 |
16.2 |
122.0 |
10.5 |
2500 |
91.0 |
10.4 |
122.0 |
15.1 |
5000 |
66.3 |
4.0 |
95.0 |
10.4 |
5.0 (MNNG) |
3176.7 |
420.9 |
- |
- |
2.5 (2 -AA) |
- |
- |
1659.7 |
266.2 |
TA 1537
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
8.3 |
2.3 |
7.3 |
4.0 |
33 |
8.7 |
3.5 |
7.7 |
3.8 |
100 |
7.3 |
3.2 |
5.7 |
2.1 |
333 |
7.7 |
4.7 |
7.3 |
5.8 |
1000 |
4.7 |
3.1 |
4.3 |
1.5 |
2500 |
3.7 |
1.2 |
4.7 |
0.6 |
5000 |
0.7 |
0.6 |
5.3 |
0.6 |
100 (AAC) | 763.3 | 36.9 | - | - |
2.5 (2 -AA) | - | - | 85.3 | 9.0 |
TA 98
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
19.7 |
4.6 |
23.0 |
1.0 |
33 |
20.7 |
6.7 |
23.3 |
6.0 |
100 |
20.0 |
3.0 |
22.3 |
3.5 |
333 |
17.0 |
7.0 |
17.7 |
4.9 |
1000 |
17.3 |
3.1 |
25.3 |
10.2 |
2500 |
19.3 |
4.0 |
24.0 |
3.6 |
5000 |
9.7 |
0.6 |
12.7 |
5.1 |
10 (NOPD) |
922.0 |
56.6 |
- |
- |
2.5 (2 -AA) |
- |
- |
854.3 |
170.8 |
Preincubation Test
TA 1535
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
8.0 |
3.0 |
9.7 |
1.5 |
33 |
9.0 |
7.2 |
6.7 |
2.1 |
100 |
10.7 |
5.7 |
7.7 |
2.1 |
333 |
8.0 |
4.6 |
8.0 |
4.4 |
1000 |
10.3 |
2.5 |
7.7 |
2.9 |
2500 |
3.7 |
2.1 |
8.0 |
3.6 |
5000 |
4.3 |
2.5 |
3.7 |
2.1 |
5.0 (MNNG) |
3529.7 |
196.4 |
- |
- |
2.5 (2 -AA) |
- |
- |
193.0 |
10.5 |
TA 100
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
92.7 |
4.2 |
95.0 |
19.7 |
33 |
84.3 |
9.9 |
93.0 |
3.5 |
100 |
93.7 |
7.6 |
90.0 |
3.0 |
333 |
74.3 |
8.0 |
81.7 |
5.9 |
1000 |
81.0 |
18.0 |
86.0 |
12.5 |
2500 |
57.0 |
5.6 |
89.3 |
5.9 |
5000 |
33.0 |
19.9 |
60.3 |
9.0 |
5.0 (MNNG) |
2659.0 |
259.1 |
- |
- |
2.5 (2 -AA) |
- |
- |
1317.7 |
40.5 |
TA 1537
Dose [µg/plate]* |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
9.7 |
3.2 |
7.3 |
2.9 |
10 / 33 |
11.3 |
1.5 |
6.3 |
2.1 |
33 / 100 |
5.7 |
1.2 |
9.3 |
1.2 |
100 / 333 |
5.7 |
3.5 |
6.0 |
2.6 |
333 / 1000 |
3.3 |
2.5 |
6.3 |
1.5 |
1000 / 2500 |
3.3 |
1.5 |
4.3 |
2.9 |
2500 / 5000 |
1.0 |
1.0 |
3.3 |
1.5 |
100 (AAC) |
702.7 |
75.8 |
- |
- |
2.5 (2 -AA) |
- |
- |
59.7 |
10.4 |
* Test concentration without S9 on the left and with S9 on the right (-S9 / + S9)
TA 98
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
17.3 |
3.8 |
22.7 |
2.5 |
33 |
12.7 |
3.1 |
18.0 |
4.6 |
100 |
16.7 |
3.8 |
19.7 |
2.1 |
333 |
9.3 |
2.1 |
17.3 |
6.7 |
1000 |
11.3 |
3.2 |
18.7 |
4.9 |
2500 |
8.0 |
1.7 |
17.3 |
5.0 |
5000 |
5.7 |
2.5 |
7.3 |
1.2 |
10 (NOPD) |
912.3 |
38.0 |
- |
- |
2.5 (2 -AA) |
- |
- |
952.7 |
18.1 |
E.coli WP2 uvrA
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
19.7 |
6.1 |
20.0 |
1.0 |
33 |
19.0 |
6.0 |
23.0 |
4.0 |
100 |
22.3 |
4.2 |
18.7 |
7.6 |
333 |
19.3 |
1.5 |
18.7 |
4.0 |
1000 |
18.3 |
2.5 |
18.0 |
6.6 |
2500 |
22.0 |
4.6 |
17.3 |
4.0 |
5000 |
13.7 |
2.3 |
18.7 |
5.0 |
5.0 (4 -NQO) |
369.0 |
32.7 |
- |
- |
60 (2 -AA) |
- |
- |
77.0 |
13.5 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
- Executive summary:
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 (TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA). The test concentrations were 33 μg - 5000 μg/plate (SPT) and 10 μg - 5000 μg/plate (PIT). Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats). Precipitation of the test substance was found depending on the strain and test conditions from about 1000 μg/plate onward. A bacteriotoxic effect was observed depending on the strain and test conditions from about 33 μg/plate onward. A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system.
Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
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