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EC number: 213-773-6 | CAS number: 1009-93-4
- 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:
- 2015-01-07 to 2015-02-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD guideline and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2,4,4,6,6-hexamethylcyclotrisilazane
- EC Number:
- 213-773-6
- EC Name:
- 2,2,4,4,6,6-hexamethylcyclotrisilazane
- Cas Number:
- 1009-93-4
- Molecular formula:
- C6H21N3Si3
- IUPAC Name:
- 2,2,4,4,6,6-hexamethyl-1,3,5,2,4,6-triazatrisilinane
- Test material form:
- other: liquid
Constituent 1
Method
- Target gene:
- Histidine operon (S. typhimurium), tryptophan operon (E. coli).
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:
- Phenobarbital/β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 10; 33; 100; 333; 1000; 2500; and 5000 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: anhydrous Acetone (purity > 99 %)
- Justification for choice of solvent/vehicle: the vehicle was chosen based on the hydrolysis and solubility properties of the test material.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- anhydrous acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100, without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- anhydrous acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- TA 1537, TA 98, without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- anhydrous acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA, without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- anhydrous acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA, with metabolic activation
- Details on test system and experimental conditions:
- ACTIVATION: The protein concentration of the S9 preparation was 39.3 mg/mL. The S9 mix included 10 % v/v S9 and the following cofactors: 8 mM MgCl2, 33 mM KCl, 5 mM glucose-6-phosphate, 4 mM NADP in 100 mM sodium-ortho-phosphate-buffer, pH 7.4. 0.5 ml S9 mix were added to a total volume of 2.7, giving a final concentration of approximately 2% S9 in the top agar.
METHOD OF APPLICATION: in agar plates for plate incorporation and preincubation
DURATION
- Preincubation period: at 37 °C for 60 minutes
- Exposure duration: 72 hours
SELECTION AGENT (mutation assays): histidine-deficient agar plates for Salmonella typhimurium and tryptophan-deficient agar plates for Escherichia coli
NUMBER OF REPLICATIONS: triplicatem plates, initial plate incorporation assay repeated using the preincubation method
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertants; condition of background lawn. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed
- Statistics:
- Relevant statistics (st.dev, mean) were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg/plate during plate incorporation, and at 2500 and 5000 μg/plate during pre-incubation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- PRECIPITATION: No precipitation of the test item occurred up to the highest investigated dose
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Strains TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA showed reduced background growth at concentration of 5000 μg/plate test material, during the plate incorporation experiment, with and without metabolic activation (Experiment I). Strains TA 1535, TA 1537 and WP2 uvrA showed reduced background growth, following incubation with the test material at 5000 μg/plate during the pre-incubation experiment, with metabolic activation.
Cytotoxicity was observed in all the strains, when treated with 2500 and 5000 μg/plate of the test substance during plate incorporation and pre-incubation experiments, with and without metabolic activation.
No significant increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Table 1. Results from plate incorporation experiment, mean revertant colonies count, with and without metabolic activation
Concentration μg/plate |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|||||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
Acetone |
14 |
18 |
20 |
12 |
36 |
23 |
137 |
158 |
49 |
38 |
Untreated |
18 |
20 |
18 |
15 |
40 |
27 |
155 |
171 |
52 |
37 |
3 μg |
12 |
21 |
19 |
12 |
40 |
22 |
140 |
167 |
49 |
41 |
10 μg |
14 |
16 |
19 |
14 |
38 |
20 |
139 |
166 |
46 |
43 |
33 μg |
13 |
23 |
22 |
10 |
35 |
22 |
141 |
163 |
45 |
37 |
100 μg |
15 |
21 |
15 |
13 |
33 |
25 |
143 |
167 |
52 |
37 |
333 μg |
15 |
21 |
20 |
13 |
40 |
24 |
139 |
166 |
46 |
41 |
1000 μg |
15 |
19 |
16 |
12 |
39 |
18 |
141 |
138 |
59 |
44 |
2500 μg |
12 |
18 |
19 |
13 |
38 |
23 |
75 |
77 |
53 |
41 |
5000 μg* |
10R |
11R |
1R* |
2R* |
8R* |
7R* |
8R* |
28R* |
19R* |
29R |
NaN310 μg |
- |
1156 |
- |
- |
- |
- |
- |
2144 |
- |
- |
4-NOPD 10 μg |
- |
- |
- |
- |
- |
3 96 |
- |
- |
- |
- |
4-NOPD 50 μg |
- |
- |
- |
89 |
- |
- |
- |
- |
- |
- |
MMS 0.2 μg |
- |
- |
- |
- |
- |
- |
- |
- |
- |
841 |
2-AA 2.5 μg |
451 |
- |
246 |
- |
3052 |
- |
3663 |
- |
|
- |
2 -AA 10.0 μL |
- |
- |
- |
- |
- |
- |
- |
- |
278 |
- |
Table 2. Results from pre-incubation experiment, mean revertant colonies count, with and without metabolic activation
Concentration µg/plate |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
|||||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
Acetone |
10 |
11 |
20 |
11 |
32 |
20 |
164 |
172 |
43 |
35 |
Untreated |
10 |
9 |
23 |
9 |
41 |
29 |
188 |
187 |
47 |
39 |
10 µg |
9 |
12 |
15 |
10 |
40 |
27 |
170 |
160 |
45 |
37 |
33 µg |
10 |
9 |
17 |
11 |
34 |
26 |
181 |
159 |
47 |
36 |
100 µg |
12 |
10 |
19 |
9 |
40 |
21 |
177 |
178 |
51 |
38 |
333 µg |
12 |
10 |
20 |
10 |
32 |
27 |
135 |
170 |
51 |
33 |
1000 µg |
11 |
12 |
19 |
7 |
36 |
20 |
137 |
108 |
47 |
35 |
2500 µg* |
10 |
2* |
18 |
1* |
26 |
4* |
62* |
43* |
39 |
28 |
5000 µg* |
0ᴿ* |
0* |
0ᴿ* |
1* |
3* |
0* |
0* |
0* |
0ᴿ* |
0* |
NaN3 10 µg |
|
1054 |
|
|
|
|
|
2128 |
|
|
4-NOPD 10 µg |
|
|
|
|
|
329 |
|
|
|
|
4-NOPD 50 µg |
|
|
|
97 |
|
|
|
|
|
|
MMS 2.0 µL |
|
|
|
|
|
|
|
|
|
645 |
2-AA 2.5 µg |
401 |
|
194 |
|
2828 |
|
3387 |
|
|
|
2-AA 10.0 µg |
|
|
|
|
|
|
|
|
387 |
|
NaN3 sodium azide
2-AA 2-aminoanthracene
4-NOPD 4-nitro-o-phenylene-diamine
MMS methyl methane sulfonate
R Reduced background growth
* Cytotoxic effect
Applicant's summary and conclusion
- Conclusions:
- Hexamethylcyclotrisilazane has been tested for mutagenicity to bacteria, in a study which was conducted according to the OECD Technical Guideline 471, in compliance with GLP. No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 in the initial plate incorporation study or the repeat experiment using the pre-incubation method, when tested up to limit concentrations. Appropriate positive, solvent and negative controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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