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EC number: 221-329-8 | CAS number: 3068-78-8
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 Jul - 24 Nov 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- (2014)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Type of assay:
- other: in vitro mammalian chromosome aberration test (migrated information)
Test material
- Reference substance name:
- N-[3-(trimethoxysilyl)propylcyclohexylamine]
- EC Number:
- 221-329-8
- EC Name:
- N-[3-(trimethoxysilyl)propylcyclohexylamine]
- Cas Number:
- 3068-78-8
- Molecular formula:
- C12H27NO3Si
- IUPAC Name:
- N-[3-(trimethoxysilyl)propyl]cyclohexanamine
- Details on test material:
- - Name of test material (as cited in study report): 3-(Cyclohexylamino)propyl trimethoxysilane
- Physical state: yellowish liquid
- Expiration date of the lot/batch: 06 Feb 2017
- Storage condition of test material: at room temperature, protected from light and moisture
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Type and identity of media (culture medium for long-term treatment and post incubation):
- MEM supplemented with 10% (v/v) fetal bovine serum, 100 U/100 µg/ml penicillin/streptomycin solution, 2 mM L-glutamine, 2.5 µg/ml amphotericin and 25 mM HEPES
Type and identity of media (culture medium for short-term treatment and post incubation):
- MEM supplemented with 100 U/100 µg/ml penicillin/streptomycin solution, 2 mM L-glutamine, 2.5 µg/ml amphotericin and 25 mM HEPES - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital/β-naphtholflavone induced rat liver S9-mix
- Test concentrations with justification for top dose:
- Preliminary experiment:
- 8, 16, 32, 63, 125, 250, 500, 1000, 1500 and 2000 µg/mL (4 h treatment, with and without metabolic activation)
Experiment I:
- 250, 500*, 1000, 1500* and 2000* μg/mL (4 h treatment, without metabolic activation)
- 250, 500*, 1000*, 1500* and 2000 μg/mL (4 h treatment, with metabolic activation)
Experiment II:
- 100, 250, 500*, 1000*, 1500* and 2000 μg/mL (21 h treatment, without metabolic activation)
* cells evaluated for chromosomal aberrations - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: A solubility test was performed with different solvents and vehicles up to the maximum recommended concentration of 2 mg/mL. According to the results of the solubility test the test item was dissolved in DMSO and diluted prior to treatment.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Remarks:
- -S9-mix: ethylmethanesulfonate (EMS): 600 µg/mL; +S9-mix: cyclophosphamide (CPA): 1.5 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 and 21 h
- Fixation time (start of exposure up to fixation or harvest of cells): 4 h treatment: 21 h; 21 h treatment: 21 h
SPINDLE INHIBITOR: colcemid (0.2 µg/mL culture medium)
STAIN: Giemsa
NUMBER OF REPLICATIONS: duplicate cultures for each test concentration and negative, solvent and positive control
NUMBER OF CELLS EVALUATED: 150 well-spread metaphases per culture (300 per test concentration)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; relative increase in cell count (RICC)
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- There are several criteria for determining a positive result: a clear and dose-related increase in the number of cells with aberrations and a biologically relevant response for at least one of the dose groups, which is higher than the laboratory negative control range. According to the OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results. A statistical evaluation could be used as an aid for interpretation of the results; a statistical evaluation of the results is nor regarded necessary. However, for the interpretation of the data, both biological and optionally evaluated statistical significance should be considered together. A test item is considered to be negative if there is no biologically relevant increase in the percentages of aberrant cells above concurrent control levels, at any dose group. Although most experiments give clearly positive or negative results, in some cases the data set precludes making a definitive judgement about the activity of the test substance.
- Statistics:
- Statistical significance at the 5% level (p <0.05) was evaluated by the Fischer´s exact test. The p value was used as a limit in judging for significance levels in comparison with the corresponding negative control. Aberrant cells without gaps were only used for the calculation. Gaps are recorded separately and reported but generally not included in the total aberration frequency calculation according to the guideline.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥1500 µg/mLwithout metabolic activation (experiment I)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: In experiment I, precipitation of the test item was noted without metabolic activation at a concentration of 2000 µg/mL and with metabolic activation at a concentration of 1500 µg/mL. In experiment II, precipitation of the test item was seen without metabolic activation at a concentration of 1500 µg/mL.
RANGE-FINDING/SCREENING STUDIES
According to the guideline the highest recommended concentration was 2 mg/mL. The test item was dissolved in DMSO. No precipitation of the test item was noted. The highest dose group evaluated in the pre-experiment was 2 mg/mL. The relative mitotic index and the relative increase in cell count (RICC) were used as parameter for toxicity. The concentrations evaluated in the main experiment are based on the results obtained in the pre-experiment.
COMPARISON WITH HISTORICAL CONTROL DATA
In experiment I without metabolic activation the aberration rate of the negative control (3%), the solvent control (2%) and two of three dose groups treated with the test item 3.7% (500 µg/mL) and 3.3% (1500 µg/mL) were within the historical control data of the testing facility (0 - 4%). An increase of aberrant cells was noted at a concentration of 2000 µg/mL (9%). With metabolic activation, the aberration rates of the negative control (2.3%), the solvent control (1.3%) and two of three dose groups treated with the test item 2% (500 µg/mL) and 1% (1000 µg/mL) were within the historical control data of the testing facility (0 - 4.3%). An increase of aberrant cells was noted at a concentration of 1500 µg/mL (11%). The increase of aberrant cells in the highest concentration without and with metabolic activation is regarded as not biologically relevant, due to precipitation in these dose groups. Precipitation might lead to artefactual effects as mentioned in the OECD guideline 473. In experiment II without metabolic activation the aberration rate of the negative control (1.3%), the solvent control (1%) and all dose groups treated with the test item (1.7% at 500, 1000 and 1500 µg/mL) were within the historical control data of the testing facility (0 - 4%). The number of aberrant cells found in the dose groups treated with the test item did not show a biologically relevant increase compared to the corresponding negative control. In addition, no dose-response relationship was observed. Moreover, no biologically relevant increase in the frequencies of polyploid cells was found after treatment with the test item.
ADDITIONAL INFORMATION ON CYTOTOXICITY
No cytotoxic effects of the test item were noted in experiment I with metabolic activation and in experiment II without metabolic activation in all dose groups evaluated (considering relative mitotic index and RICC). In experiment I without metabolic activation, no cytotoxic effects of the test item were noted considering the relative mitotic index. However, considering the RICC, cytotoxic effects were observed at 1500 µg/mL and higher.
ACCEPTABILITY OF THE TEST
The chromosomal aberration assay is considered acceptable if it meets the following criteria: the number of aberration found in the negative control and/or solvent controls falls within the range of historical laboratory control data; concurrent positive controls should induce responses that are comparable with those generated in the historical positive control data base and produce a statistically significant increase compared with the concurrent negative control; the proliferation rate of the solvent control should be similar to the corresponding negative control value.
Any other information on results incl. tables
Table 1: Preliminary experiment - Cytotoxicity data
Dose Group [µg/ml] |
Relative Mitotic Index [%] |
RICC [%] |
Without metabolic activation |
||
Negative control |
109 |
102 |
Solvent |
100 |
100 |
8 |
110 |
109 |
16 |
95 |
122 |
32 |
112 |
93 |
63 |
122 |
122 |
125 |
124 |
105 |
250 |
103 |
105 |
500 |
101 |
120 |
1000 |
106 |
131 |
1500 |
113 |
129 |
2000 |
96 |
106 |
With metabolic activation |
||
Negative control |
110 |
123 |
Solvent |
100 |
100 |
8 |
124 |
101 |
16 |
126 |
95 |
32 |
99 |
123 |
63 |
106 |
105 |
125 |
132 |
94 |
250 |
125 |
89 |
500 |
106 |
93 |
1000 |
106 |
84 |
1500 |
131 |
95 |
2000 |
135 |
85 |
The mitotic index was determined in 1000 cells/culture of each test group.
RICC: Relative Increase in Cell Count
Table 2: Chromosome aberrations in Chinese hamster V79 cells with and without metabolic activation - Experiment I + II
Test item |
Concentration [µg/ml] |
Relative Mitotic Index [%] |
RICC [%] |
Aberrant Cells [%] |
|
with gaps |
without gaps |
||||
Exposure period 4 h, fixation time 21 h, without S9-mix |
|||||
Negative control |
0 |
110 |
133 |
5.7 |
3.0 |
Solvent |
0 |
100 |
100 |
4.0 |
2.0 |
EMS |
600 |
105 |
70 |
15.7 |
11.7 |
Test item |
500 |
90 |
59 |
5.7 |
3.7 |
1500 |
75 |
50 |
5.0 |
3.3 |
|
2000 P |
72 |
67 |
11.2 |
9.0 |
|
Exposure period 4 h, fixation time 21 h, with S9-mix |
|||||
Negative control |
0 |
105 |
93 |
2.7 |
2.3 |
Solvent |
0 |
100 |
100 |
2.7 |
1.3 |
CPA |
1.5 |
112 |
113 |
11.7 |
7.0 |
Test item |
500 |
89 |
91 |
3.3 |
2.0 |
1000 |
87 |
86 |
2.7 |
1.0 |
|
1500 P |
94 |
81 |
13.7 |
11.0 |
|
Exposure period 21 h, fixation time 21 h, without S9-mix |
|||||
Negative control |
0 |
86 |
96 |
2.3 |
1.3 |
Solvent |
0 |
100 |
100 |
2.7 |
1.0 |
EMS |
600 |
74 |
62 |
21.3 |
20.9 |
Test item |
500 |
110 |
94 |
3.0 |
1.7 |
1000 |
99 |
74 |
3.0 |
1.7 |
|
1500 P |
92 |
85 |
3.7 |
1.7 |
P: precipitation
CPA: cyclophosphamide
EMS: ethylmethanesulfonate
Relative Mitotic Index: the relative mitotic index is related to the solvent controls and determined in 1000 cells/culture of each test group
RICC: relative increase in cell count, calculated by the increase in cell number of the test groups compared to the control groups.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described in vitro chromosome aberration test performed according to OECD guideline 473 and under the experimental conditions reported, that the test item did only induce structural chromosome aberrations in the V79 Chinese hamster cell line in the highest concentration with and without metabolic activation after a short term treatment of 4 h. However, these increased aberration rates are considered as not biologically relevant, due to precipitation. Therefore, the test item is considered to be non-clastogenic in this chromosome aberration test.
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