Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 252-161-3 | CAS number: 34708-08-2
- 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

Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In a bacterial reverse mutation assay / Ames test, conducted according to OECD 471 and in compliance with GLP, triethoxy(3-thiocyanatopropyl)silane was found to be negative in both the presence and absence of metabolic activation. The tested strains included Salmonella typhimurium: TA98, TA100, TA1535 and TA1537 as well as Escherichia coli WP2 (Evonik Degussa, 2000).
In a cytogenicity study in mammalian cells (chromosome aberration), conducted according to OECD 473 and in compliance with GLP, the potential of triethoxy(3-thiocyanatopropyl)silane to induce structural chromosome aberrations in Chinese hamster V79 cells was evaluated. A dose-related increase in the number of aberrations was observed at all concentrations tested with and without metabolic activation. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is clastogenic (causes structural aberrations in chromosomes) under the conditions of the test. No evidence of polyploidy was observed (BSL Bioservice, 2012).
In a mutagenicity study, conducted according to OECD 476 and in compliance with GLP, a dose-related increase in the mutant frequency was observed in mouse lymphoma L5178Y cells. Therefore, it is concluded that the test substance is positive with metabolic activation. No clastogenic effects were observed (BSL Bioservice, 2011).
Link to relevant study records
- 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:
- 2000-05-09 to 2000-05-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system: Male Wistar rats
- source of S9 : RCC (Cytotest Cell Research GmbH), Roßdorf, Germany.
- method of preparation of S9 mix: Wistar male rats received 80 mg/kg bw phenobarbital (i.p) and 80 mg/kg bw beta-naphthoflavone (oral) during 3 consecutive days and were sacrificed 24 h after the last administration. The livers were removed from the animals and homogenised. The S9 mix was prepared freshly before use: one part S9 fraction mixed with 9 parts of a cofactor solution.
- concentration or volume of S9 mix and S9 in the final culture medium: 10%
- quality controls of S9: enzymatic activity, sterility and protein content - Test concentrations with justification for top dose:
- 50-5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Not reported - Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 (without activation)
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100 (without activation)
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- TA 102 (without activation)
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535 (without activation)
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 (without activation)
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA (without activation)
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoflouorene
- Remarks:
- All strains (with activation)
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- All strains (with activation)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
ACTIVATION:
DURATION
- Preincubation period: 30 minutes
- Expression time (cells in growth medium): 72 hours
NUMBER OF REPLICATIONS: 3 plates for each test concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; background lawn assessment - Evaluation criteria:
- For a test compound or a test substance to be considered positive, it must (in two independent experiments) cause at least a doubling in the mean revertants per plate of at least one tester strain. The increase must be accompanied by a dose response towards increasing concentrations of the test article. Single increases in revertant frequencies which are not dose-related and not reproducible in two independent tests are considered non-relevant. However, when increases occur in both tests, this will be taken as an indication of a mutagenic effect.
A reduction in the number of spontaneous revertants, and / or a thinning of the background lawn is indicative of toxicity. - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation noted at 1600 and 5000 µg/plate
COMPARISON WITH HISTORICAL CONTROL DATA: Results were within range of historical control data - Conclusions:
- Triethoxy(3-thiocyanatopropyl)silane has been tested in a reliable study conducted in accordance with OECD 471 (1997) and in compliance with GLP using Salmonella typhimurium strains TA 98, 100, 1535, 1537 and 1538, and E.coli WP2uvrA. No evidence of test substance induced increase in the number of revertants was observed up to limit concentrations in any of the bacteria tested without and with metabolic activation in either the initial plate incorporation assay or the repeat experiment using the preincubation method. Appropriate untreated, solvent and positive controls were included and gave expected results. In conclusion, the test substance is non-mutagenic under the conditions of the test.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-10-19 to 2011-12-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and ß-naphthoflavone-induced rat liver S9 mix containing 8 mM MgCl2; 22 mM KCl 5 mM Glucose-6-phosphate and 4 mM NADP
- Test concentrations with justification for top dose:
- Pre-experiment:
with and without metabolic activation:
0.020, 0.039, 0.078, 0.16, 0.31, 0.63, 1.25, 2.50, 5.0 and 10.0 mM
Main Experiment :
without metabolic activation:
0.40, 0.60 and 0.80 mM
with metabolic activation:
0.15, 0.30 and 0.50 mM - Vehicle / solvent:
- -Vehicle (s)/solvent(s) used: DMSO (final concentration of 1% solvent v/v)
- Justification for choice of solvent/vehicle: The test item could be dissolved in DMSO and was compatible with the survival of the cells. - Untreated negative controls:
- yes
- Remarks:
- 900 µg/mL
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- 0.83 µg/mL
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- TREATMENT TIME:
4 hours (Main Experiment with and without metabolic activation)
FIXATION INTERVAL: 20 hours (Main Experiment with and without metabolic activation)
NUMBER OF REPLICATIONS: 1 experiment
NUMBER OF CELLS SEEDED: 1 x 10^4 - 5 x 10^4 cells
NUMBER OF CULTURES: two cultures per concentration
NUMBER OF CELLS SCORED: 200 cells per concentration (100 cells per culture)
DETERMINATION OF CYTOTOXICITY: Mitotic index, cell density - Evaluation criteria:
- There are several criteria for determining a positive result:
- a clear and dose-related increase in the number of cells with aberrations,
- a biologically relevant response for at least one of the dose groups, which is higher than the laboratory negative control range (0.0% - 4.0% aberrant cells (with and without metabolic activation)). - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 0.6 mM (without metabolic activation)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Triethoxy(3-thiocyanatopropyl)silane has been tested in a reliable in vitro chromosomal aberration test conducted according to OECD 473 and in compliance with GLP. A dose-related increase in the number of aberrations was observed at all concentrations tested with and without metabolic activation. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is clastogenic (causes structural aberrations in chromosomes) under the conditions of the test. No evidence of polyploidy was observed.
- Executive summary:
To investigate the potential of triethoxy(3-thiocyanatopropyl)silane to induce structural chromosome aberrations in Chinese hamster V79 cells, an in vitro chromosome aberration assay was carried out.
The chromosomes were prepared 20 h after start of treatment with the test item. The treatment interval was 4 h with and without metabolic activation in the main experiment. Duplicate cultures were treated at each concentration. 100 metaphases per culture were scored for structural chromosomal aberrations.
The test item could be dissolved in DMSO and was compatible with the survival of the cells.
The following concentrations were evaluated for the microscopic analysis of chromosomal aberrations:
without metabolic activation: 0.40, 0.60 and 0.80 mM
with metabolic activation: 0.15, 0.30 and 0.50 mM
In the main experiment precipitation of the test item was noted after incubation with the test item without metabolic activation at a concentration of 0.80 mM, with metabolic activation no precipitation was observed.
Toxic effects of the test item were observed in the main experiment without metabolic activation at concentrations of 0.60 mM and higher, with metabolic activation no toxic effects were noted at the concentrations evaluated.
A clear increase of aberrant cells was found in the main experiment with and without metabolic activation at all concentrations evaluated. In addition, a dose response relationship was observed.
In the main experiment with and without metabolic activation no biologically relevant increase in the frequencies of polyploid cells was observed after treatment with the test item as compared to the controls.
EMS (900 µg/mL) and CPA (0.83 µg/mL) were used as positive controls and induced distinct and biologically relevant increases in cells with structural chromosomal aberrations.
The positive controls induced the appropriate responses.
There was a concentration-related positive response of test item induced over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OPPTS 870.5375; OECD 473 for in vitro cytogenetic mutagenicity data.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011-09-26 to 2011-11-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: IWGT Recommendations
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Germany)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine kinase
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and ß-Naphthoflavone-induced rat liver S9 mix containing 8 mM MgCl2; 33 mM KCl; 5 mM Glucose-6-phosphate and 4 mM NADP.
- Test concentrations with justification for top dose:
- Pre-experiment with [0.2, 0.5 and 2.5 mM] and without metabolic activation [0.2, 0.5, 1 and 2 mM]
Main Experiment
with metabolic activation: 0.05, 0.1, 0.2, 0.5, 0.7, 0.9, 1.1 and 1.3 mM
without metabolic activation: 0.005, 0.01, 0.02, 0.05, 0.1, 0.2, 0.5 and 1 mM - Vehicle / solvent:
- Based on the solubility test DMSO was used as solvent (final concentration 1% DMSO v/v).
- Untreated negative controls:
- yes
- Remarks:
- 2.5 µg/ml
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Untreated negative controls:
- other: 300 µg/ml
- Positive control substance:
- ethylmethanesulphonate
- Untreated negative controls:
- other: 10 µg/ml
- Positive control substance:
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: suspended in medium
DURATION: 4 h (short-term exposure)
Expression time (cells in growth medium): 48 h
Selection time (if incubation with selection agent): about 14 days
SELECTION AGENT ( mutation assay) 5 µg/ml trifluorothymidine
NUMBER OF REPLICATIONS: one experiment with single exposure; cells were seeded in 4 plates and evaluated
NUMBER OF CELLS SEEDED: 2000 cells per well
DETERMINATION OF CYTOTOXICITY: relative total growth (RTG) - Evaluation criteria:
- The test item is considered mutagenic if following criteria are met:
-The induced mutant frequency meets or exceeds the Global Evaluation factor (GEF) of 126 per 106 cells
- A dose-dependent increase in mutant frequency is detected.
Besides, combined with a positive effect in the mutant frequency, an increased occurrence of small colonies (≥40% of total colonies) is an indication for potential clastogenic effects and/or chromosomal aberrations.
According to the OECD guideline, the biological relevance is considered first for the interpretation of results. Statistical methods might be used as an aid in evaluation the test result.
A test item is considered to be negative if the induced mutant frequency is below the GEF and the trend test is negative. - Statistics:
- The non-parametric Mann-Whitney test is applied to the mutation data to prove the dose groups for any significant difference in mutant frequency compared to the negative /solvent controls.
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Triethoxy(3-thiocyanatopropyl)silane has been tested for mutagenicity to mammalian cells in a reliable study conducted according to OECD TG 476 and in compliance with GLP using L5178Y cells. A dose-related increase in mutant frequency above the global evaluation factor was observed at concentrations of 1mM and above in the main experiment with metabolic activation. Appropriate solvent and positive controls were included and gave expected results. It is therefore concluded that the test substance is mutagenic in the in vitro mammalian cell gene mutation assay (thymidine kinase locus) in mouse lymphoma L5178Y cells. No clastogenic effects (increase in number of small colonies) were observed in this study.
- Executive summary:
The test item triethoxy(3-thiocyanatopropyl)silane was assessed for its potential to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y.
The selection of the concentrations used in the main experiment was based on data from the pre-experiment. In the main experiment 1.3 mM (with metabolic activation) and 1 mM (without metabolic activation) were selected as the highest concentrations. The experiment with and without metabolic activation was performed as a 4 h short-term exposure assay. Based on the solubility test DMSO was used as solvent (final concentration 1% DMSO v/v).
The test item was investigated at the following concentrations:
with metabolic activation:
0.05, 0.1, 0.2, 0.5, 0.7, 0.9, 1.1 and 1.3 mM
and without metabolic activation:
0.005, 0.01, 0.02, 0.05, 0.1, 0.2, 0.5 and 1 mM
Precipitation of the test item was noted in the pre-experiment at a concentration of 2.5 mM. Growth inhibition was observed in the main experiment with and without metabolic activation.
In the main experiment with metabolic activation the relative total growth (RTG) was 9.4% for the highest concentration (1.3 mM) evaluated. The highest concentration evaluated without metabolic activation was 1 mM with an RTG of 13.1%. In the main experiment a biologically relevant increase of mutants was found after treatment with the test item with metabolic activation, without metabolic activation no biologically relevant increase of mutants was found after treatment with the test item. The Global Evaluation Factor (GEF; defined as the mean of the negative/vehicle mutant frequency plus one standard deviation; data gathered from ten laboratories) was exceeded by the induced mutant frequency at a concentration of 1.1 mM and higher in the main experiment with metabolic activation.
A dose-response relationship was observed.
However, in the main experiment colony sizing showed no clastogenic effects induced by the test item under the experimental conditions (with and without metabolic activation).
EMS, MMS and B[a]P were used as positive controls and showed distinct and biologically relevant effects in mutation frequency. Additionally, MMS and B[a]P significantly increased the number of small colonies, thus proving the efficiency of the test system to indicate potential clastogenic effects.
This study is classified as acceptable. This study satisfies the requirements for Test Guidelines OPPTS 870.5300, OECD 476 for in vitro mutagenicity (mammalian forward gene mutation) data.
Referenceopen allclose all
Table 2: Experiment 1 Plate incorporation Number of revertants per plate
| TA 98 | TA 100 | TA 102 | ||||||
Conc. | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic |
Negative Control | 13 | 13 | No | 129 | 237 | No | 380 | 434 | No |
0* | 15 | 9 | No | 104 | 2219 | No | 329 | 351 | No |
50 | 18 | 2 | No | 103 | 237 | No | 398 | 312 | No |
160 | 16 | 7 | No | 111 | 233 | No | 388 | 308 | No |
500 | 16 | 5 | No | 130 | 225 | No | 350 | 347 | No |
1600 | 22 | 7 | No | 135 | 223 | No | 345 | 298 | No |
5000 | 13 | 7 | No | 138 | 199 | No | 349 | 268 | No |
Positive control | 100 | 2216 | No | 587 | 1637 | No | 1205 | 837 | No |
Positive control 2 | - | 1606 | No | - | 1524 | No | - | 522 | No |
*solvent control with DMSO
Table 2: Experiment 1 Plate incorporation Number of revertants per plate
| TA 1535 | TA 1537 | WP2 uvrA | ||||||
Conc. | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic |
Negative Control | 12 | 15 | No | 13 | 16 | No | 12 | 12 | No |
0* | 14 | 8 | No | 12 | 15 | No | 9 | 11 | No |
50 | 13 | 7 | No | 14 | 17 | No | 11 | 15 | No |
160 | 11 | 7 | No | 9 | 12 | No | 9 | 14 | No |
500 | 13 | 9 | No | 11 | 16 | No | 8 | 12 | No |
1600 | 13 | 10 | No | 17 | 11 | No | 11 | 14 | No |
5000 | 10 | 10 | No | 11 | 9 | No | 9 | 12 | No |
Positive control | 576 | 31 | No | 43 | 69 | No | 185 | 40 | No |
Positive control 2 | - | 142 | No | - | 116 | No | - | 20 | No |
*solvent control with DMSO
Table 3: Experiment 2 Pre incubation Number of revertants per plate
| TA 98 | TA 100 | TA 102 | ||||||
Conc. | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic |
Negative Control | 26 | 30 | No | 196 | 197 | No | 406 | 365 | No |
0* | 23 | 33 | No | 181 | 182 | No | 350 | 361 | No |
50 | 31 | 34 | No | 182 | 185 | No | 391 | 360 | No |
160 | 30 | 31 | No | 195 | 179 | No | 361 | 336 | No |
500 | 37 | 31 | No | 196 | 174 | No | 374 | 359 | No |
1600 | 27 | 35 | No | 200 | 175 | No | 399 | 334 | No |
5000 | 27 | 28 | No | 191 | 200 | No | 385 | 277 | No |
Positive control | 137 | 1966 | No | 680 | 1331 | No | 1390 | 1173 | No |
Positive control 2 | - | 1113 | No | - | 1064 | No | - | 471 | No |
*solvent control with DMSO
Table 3: Experiment 2 Pre incubation Number of revertants per plate
| TA 1535 | TA 1537 | WP2 uvrA | ||||||
Conc. | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic |
Negative Control | 15 | 11 | No | 6 | 10 | No | 13 | 11 | No |
0* | 16 | 9 | No | 9 | 9 | No | 10 | 13 | No |
50 | 13 | 10 | No | 8 | 7 | No | 13 | 17 | No |
160 | 16 | 11 | No | 9 | 15 | No | 12 | 18 | No |
500 | 11 | 10 | No | 6 | 10 | No | 14 | 16 | No |
1600 | 12 | 11 | No | 11 | 13 | No | 8 | 16 | No |
5000 | 12 | 12 | No | 9 | 14 | No | 12 | 12 | No |
Positive control | 555 | 24 | No | 39 | 78 | No | 222 | 52 | No |
Positive control 2 | - | 128 | No | - | 71 | No | - | 22 | No |
*solvent control with DMSO
Results of chromosome analysis without metabolic activation | |||||||||||||||
Cytotoxicity | Chromatid aberrations | Isochromatid aberrations | rel. Mitotic index (%) | rel. Cell density (%) | Poly-ploidy | mean % aberrant cells | |||||||||
Scored cells | gaps | breaks | inter-changes | other | gaps | breaks | inter-changes | other | incl. Gaps | excl. Gaps | |||||
Main Experiment | |||||||||||||||
negative control | 200 | - | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 87 | 100 | 1 | 2.5 | 1.5 |
solvent control | 200 | - | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 100 | 1 | 1.0 | 0.0 |
0.02 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 101 | n.d. | n.d. | n.d. | n.d. |
0.03 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 95 | n.d. | n.d. | n.d. | n.d. |
0.06 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 97 | n.d. | n.d. | n.d. | n.d. |
0.08 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 85 | n.d. | n.d. | n.d. | n.d. |
0.10 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 91 | n.d. | n.d. | n.d. | n.d. |
0.20 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 80 | n.d. | n.d. | n.d. | n.d. |
0.40 mM | 200 | no | 5 | 12 | 4 | 2 | 1 | 0 | 0 | 0 | 73 | 89 | 2 | 10.0 | 7.5 |
0.60 mM | 200 | yes | 7 | 22 | 1 | 1 | 1 | 0 | 0 | 1 | 48 | 77 | 1 | 11.5 | 8.5 |
0.80 mM | 200 | yes | 6 | 28 | 4 | 1 | 0 | 1 | 0 | 0 | 32 | 48 | 0 | 13.5 | 12.0 |
EMS 900 µg/mL | 200 | - | 7 | 6 | 8 | 3 | 1 | 0 | 6 | 0 | 105 | 84 | 1 | 12.5 | 9.5 |
Results of chromosome analysis | |||||||||||||||
with metabolic activation | |||||||||||||||
Cytotoxicity | Chromatid aberrations | Isochromatid aberrations | rel. Mitotic index (%) | rel. Cell density (%) | Poly-ploidy | mean % aberrant cells | |||||||||
Scored cells | gaps | breaks | inter-changes | other | gaps | breaks | inter-changes | other | incl. Gaps | excl. Gaps | |||||
Main Experiment | |||||||||||||||
negative control | 200 | - | 3 | 3 | 2 | 0 | 0 | 0 | 1 | 0 | 101 | 101 | 1 | 4.5 | 3.0 |
solvent control | 200 | - | 6 | 4 | 0 | 0 | 1 | 0 | 0 | 0 | 100 | 100 | 1 | 5.0 | 2.0 |
0.02 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 98 | n.d. | n.d. | n.d. | n.d. |
0.05 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 96 | n.d. | n.d. | n.d. | n.d. |
0.08 mM | - | no | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 89 | n.d. | n.d. | n.d. | n.d. |
0.15 mM | 200 | no | 8 | 10 | 0 | 0 | 0 | 0 | 0 | 2 | 86 | 95 | 0 | 8.5 | 6.0 |
0.30 mM | 200 | no | 3 | 15 | 3 | 1 | 0 | 1 | 0 | 2 | 87 | 94 | 2 | 10.0 | 9.0 |
0.50 mM | 200 | no | 4 | 31 | 6 | 1 | 0 | 0 | 0 | 1 | 83 | 82 | 0 | 15.0 | 14.5 |
0.75 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 63 | n.d. | n.d. | n.d. | n.d. |
1.00 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 45 | n.d. | n.d. | n.d. | n.d. |
1.25 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 12 | n.d. | n.d. | n.d. | n.d. |
1.50 mM | - | yes | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | n.d. | 28 | n.d. | n.d. | n.d. | n.d. |
CPA 0.83 µg/mL | 200 | - | 7 | 13 | 6 | 0 | 0 | 1 | 0 | 1 | 106 | 99 | 2 | 11.0 | 9.5 |
n.d. not determined
Summary of mutagenicity data with and without metabolic activation
1 Without metabolic activation
Concentration (mM) | RCE % | RTG % | MF (mutants /10x8 cells) | IMF (mutants /10x8 cells) | GEF exceeded | Statistical significance |
Negative control 1 | 103.2 | 122.9 | 69.4 | / | / | / |
Negative control 2 | 100.4 | 121.0 | / | / | / | |
Solvent control 1 | 100.0 | 100.0 | 66.4 | / | / | / |
Solvent control 2 | / | / | / | |||
0.005 | 101.1 | 110.1 | 67.1 | 0.8 | - | - |
0.01 | 99.6 | 104.1 | 69.1 | 2.7 | - | - |
0.02 | 109.5 | 119.3 | 50.8 | -15.5 | - | - |
0.05 | 103.2 | 108.4 | 85.9 | 19.5 | - | - |
0.1 | 112.3 | 61.3 | 74.7 | 8.3 | - | - |
0.2 | 92.6 | 35.8 | 93.0 | 26.7 | - | - |
0.5 | 96.8 | 26.1 | 113.1 | 46.7 | - | + |
1 | 96.8 | 13.1 | 143.3 | 76.9 | - | + |
Positive control 1 | 94.0 | 99.6 | 622.7 | 556.3 | + | + |
Positive control 2 | 92.6 | 88.1 | 456.8 | 390.5 | + | + |
2 With metabolic activation
Concentration (mM) | RCE % | RTG % | MF (mutants /10x8 cells) | IMF (mutants /10x8 cells) | GEF exceeded | Statistical significance |
Negative control 1 | 100.0 | 93.4 | 88.0 | / | / | / |
Negative control 2 | 100.0 | 106.2 | / | / | / | |
Solvent control 1 | 100.0 | 100.0 | 84.6 | / | / | / |
Solvent control 2 | / | / | / | |||
0.05 | 103.5 | 97.3 | 72.7 | -11.9 | - | - |
0.1 | 90.2 | 91.3 | 107.2 | 22.6 | - | - |
0.2 | 100.7 | 65.2 | 127.5 | 42.9 | - | + |
0.5 | 93.7 | 34.8 | 161.0 | 76.4 | - | + |
0.7 | 101.4 | 35.8 | 130.0 | 45.5 | - | + |
0.9 | 95.8 | 30.1 | 186.3 | 101.8 | - | + |
1.1 | 95.8 | 22.5 | 226.7 | 142.1 | + | + |
1.3 | 86.0 | 9.4 | 236.2 | 151.6 | + | + |
Positive control 1 | 82.5 | 44.2 | 817.8 | 733.3 | + | + |
RCE = Relative cloning efficiency GEF = Global evaluation factor
RTG = Relative total growth
MF = Mutant frequency IMF = Induced mutant frequency
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Description of key information
Based on the positive response in the in vitro studies, an in vivo comet assay is being carried out. When available, the sections herein will be updated accordingly.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Triethoxy(3-thiocyanatopropyl)silane has been tested in a reliable study conducted in accordance with OECD 471 (1997) and in compliance with GLP using Salmonella typhimurium strains TA 98, 100, 1535, 1537 and 1538, and E.coli WP2uvrA (Evonik Degussa, 2000). No evidence of test substance induced increase in the number of revertants was observed up to limit concentrations in any of the bacteria tested with and without metabolic activation in either the initial plate incorporation assay or the repeat experiment using the preincubation method. Appropriate untreated, solvent and positive controls were included and gave expected results. It is concluded that the test substance is non-mutagenic under the conditions of the test.
Information on the potential for triethoxy(3-thiocyanatopropyl)silane to cause chromosome aberrations in mammalian cells is available from a reliable study conducted according to OECD 473 and in compliance with GLP (BSL Bioservice, 2012). A dose-related increase in the number of aberrations was observed at all concentrations tested with and without metabolic activation. Appropriate solvent and positive controls were included and gave expected results. It is concluded that the test substance is clastogenic (causes structural aberrations in chromosomes) under the conditions of the test. No evidence of polyploidy was observed.
Triethoxy(3-thiocyanatopropyl)silane has been tested for mutagenicity to mammalian cells in a reliable study conducted according to OECD 476 and in compliance with GLP using L5178Y cells (BSL Bioservice, 2011). A dose-related increase in mutant frequency above the global evaluation factor was observed at concentrations of 1mM and above in the main experiment with metabolic activation. Appropriate solvent and positive controls were included and gave expected results. It is therefore concluded that the test substance is mutagenic in the in vitro mammalian cell gene mutation assay (thymidine kinase locus) in mouse lymphoma L5178Y cells. No clastogenic effects (increase in number of small colonies) were observed in this study.
Evidence of clastogenicity and mutagenicity to mammalian cells was obtained from the in vitro cytogenicity and mutagenicity studies using mammalian cells. Therefore, an in vivo comet assay is being conducted to evaluate the potential in vivo.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Route: .live2