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EC number: 240-465-9 | CAS number: 16415-13-7
- 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
Gene mutation (Bacterial reverse mutation assay / Ames test, R/A from
CAS 16415-12-6 and CAS 2943-75-1): S. typhimurium TA 98, TA 100, TA
1535, TA 1537, and E. coli WP2 uvrA: negative with and without metabolic
activation (OECD 471, GLP)
Mammalian cytogenicity (Chromosome Aberration, R/A from CAS 16415-12-6
and CAS 2943-75-1): negative with and without metabolic activation (OECD
473, GLP)
Mammalian mutagenicity (Mouse lymphoma assay, R/A from CAS 2943-75-1):
negative with and without metabolic activation (OECD 476, GLP)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- RTG of 14.6% and 9.7% without metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: CAS 2943-75-1, BSL, 2012
- Conclusions:
- Interpretation of results: negative
Triethoxyoctylsilane has been tested for mutagenicity to mammalian cells in a reliable study conducted according to OECD TG 476 and in compliance with GLP. No biologically relevant increase in mutation rate was found in mouse lymphoma L5178Y cells with or without metabolic activation in either the initial or the repeat experiment, up to limit and cytotoxic concentrations. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in genetic toxicity potential. - Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium, other: 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:
- not examined
- Positive controls validity:
- valid
- Key result
- 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:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: CAS 16415-12-6, Evonik, 2011
- Conclusions:
- Interpretation of results: negative
In a study according to OECD 471 and in compliance with GLP no mutagenic effect was observed for the source substances tested up to the limit concentration in any of the test strains in three independent experiments with and without metabolic activation. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in genetic toxicity potential. - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- Please refer to the attached justification below and the overall justification for grouping of substances attached in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- 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:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 20 µg/mL (- S9-mix); 50 µg/mL (+ S9-mix)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: CAS 16415-12-6, RTC, 2005
- Conclusions:
- Interpretation of results: negative
The source substances were tested according to OECD 473 under GLP. The source substances did not induce any statistically significant, dose-related increases in the frequency of cells with chromosomal aberrations either in the presence or absence of metabolic activation or after various exposure times. The source substances were therefore considered to be non-clastogenic to Chinese Hamster Ovary (CHO) cells in vitro under the conditions of the tests. As explained in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in genetic toxicity potential.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
No data on genetic toxicity in mammalian cells in vitro is available for triethoxyhexadecylsilane (CAS 16415-13-7). Therefore, the risk assessment was performed based on the available data from the source substances triethoxy(octyl)silane (CAS 2943-75-1) and hexadecyltrimethoxysilane (CAS 16415-12-6). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from analogue substances has been applied to support the human health hazard assessment of triethoxyhexadecylsilane (CAS 16415-13-7).
Overview of genetic toxicity
CAS |
16415-13-7 (a) |
16415-12-6 (b) |
2943-75-1 9 (b) |
Chemical name |
Triethoxyhexadecylsilane |
Hexadecyltrimethoxysilane |
Triethoxyoctylsilane |
Molecular weight |
388.34 g/mol |
346.62 g/mol |
g/mol |
Bacterial mutagenicity |
RA 16415-12-6 RA 2943-75-1 |
Experimental result: negative |
Experimental result: negative |
Mammalian cytogenicity |
RA 16415-12-6 RA 2943-75-1 |
Experimental result: negative |
Experimental result: negative |
Mammalian mutagenicity |
RA 2943-75-1 |
No data |
Experimental result: negative |
(a) The substance subject to registration is indicated in bold font.
(b) Reference (read-across) substances are indicated in normal font.
The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Triethoxyhexadecylsilane (CAS 16415-13-7). A detailed supporting report is provided in the target entry.
Discussion
Genetic toxicity (mutagenicity) in bacteria in vitro
A reliable bacterial gene mutation study (Ames test) performed according to OECD TG 471 and in compliance with GLP with hexadecyltrimethoxysilane (CAS 16415-12-6) is available (Evonik, 2011). The strains Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA were tested according to the plate incorporation procedure in the absence and presence of a metabolic activation system (Aroclor 1254-induced rat liver S9-mix). Two independent experiments were conducted in three repetitions at each concentration from 62 to 5000 µg/plate (experiment I) and 1000 to 5000 µg/plate (experiment II). No cytotoxicity was observed with the test item up to 5000 µg/plate in the absence and presence of metabolic activation. Precipitation was recorded at concentrations of ≥1000 µg/plate. Appropriate solvent (acetone) and positive controls were included and gave the expected results. No significant increase in the number of revertants was observed in any of the tester strains with and without metabolic activation. Therefore, the test material was considered to be non-mutagenic under the conditions of the test.
A further reliable bacterial gene mutation study (Ames test) performed according to OECD TG 471 and in compliance with GLP with triethoxyoctylsilane (CAS 2943-75-1) is available (MA Bioservices, 1998). The strains Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvrA were tested according to the pre-incubation procedure in the absence and presence of a metabolic activation system (Aroclor 1254-induced rat liver S9-mix). Two independent experiments were conducted in three repetitions at each concentration from 75 to 5000 µg/plate. No cytotoxicity was observed with the test item up to 5000 µg/plate in the absence and presence of metabolic activation. Precipitation was recorded at concentrations of ≥1000 µg/plate. Appropriate solvent (acetone) and positive controls were included and gave the expected results. No significant increase in the number of revertants was observed in any of the tester strains with and without metabolic activation. Therefore, the test material was considered to be non-mutagenic under the conditions of the test.
Genetic toxicity (cytogenicity) in mammalian cells in vitro
In the chromosome aberration assay, performed according to OECD TG 473 and in compliance with GLP, Chinese Hamster Ovary (CHO) cells were treated with hexadecyltrimethoxysilane (CAS 16415-12-6) at concentrations from 10.2 to 1300 µg/mL in the presence and absence of metabolic activation (RTC, 2005). The cells were treated for 3 h (with and without metabolic activation, experiment I) and for 20 h (without metabolic activation, experiment II). After 20 h the cells were fixed and stained with Giemsa after previous exposure to the spindle inhibitor colcemid. Appropriate solvent (ethanol) and positive controls were included and gave the expected results. Cytotoxicity was recorded at concentrations ≥20.3 µg/mL (20 h exposure) in the absence of metabolic activation. The test material did not induce any statistically significant, dose-related increases in the frequency of cells with chromosomal aberrations either in the presence or absence of metabolic activation or after various exposure times. The test material was therefore considered to be non-clastogenic to CHO cells in vitro under the conditions of the test.
In a further chromosome aberration assay, performed according to OECD TG 473 and in compliance with GLP, Chinese Hamster Ovary (CHO), cells were treated with triethoxyoctylsilane (CAS 2943-75-1) at concentrations from 8.5 to 20 µg/mL (6 h exposure, without metabolic activation), 21.3 to 50 µg/mL (6 h exposure, with metabolic activation) and 8.5 to 20 µg/mL (24 and 48 h exposure, without metabolic activation) in the presence or absence of metabolic activation (MA Bioservices, 1997). After appropriate incubation time the cells were fixed and stained with Giemsa after previous exposure to the spindle inhibitor colcemid (0.1 µg/mL). Appropriate solvent (ethanol) and positive controls were included and gave the expected results. No cytotoxicity was observed up to limit concentrations. The test substance did not induce statistically and biologically significant increases in the chromosomal aberration frequency of CHO (Chinese hamster ovary) cells. It is therefore concluded that the test substance is negative for the induction of chromosome aberrations (not clastogenic) in vitro under the conditions of the test.
Genetic toxicity (mutagenicity) in mammalian cells in vitro
An in vitro Mammalian Cell Gene Mutation Test was performed with triethoxyoctylsilane (CAS 2943-75-1) in mouse lymphoma L5178Y cells (heterozygous at the thymidine kinase locus) according to OECD TG 476 and under GLP (BSL, 2012). The cells were treated with the test substance in quadruplicates, together with vehicle (THF) and positive controls. 4 hour exposures were used both with (phenobarbital and ß-naphthoflavone-induced rat liver S9-mix) and without metabolic activation in Experiment l and with metabolic activation in Experiment II. In Experiment II, the exposure time without metabolic activation was increased to 24 hours. The dose range of test material in the first experiment was 0.1 to 10 mM following the results of a preliminary toxicity test with evidence of toxicity at concentrations ≥0.5 mM in the absence of metabolic activation. Experiment II was performed using the dose range of 0.15 to 10 mM with metabolic activation and 0.001 to 0.20 mM without metabolic activation. A precipitate of test material was observed in Experiment I with (10 mM) and without (≥7.5 mM) metabolic activation and in Experiment II with (≥8.0 mM) metabolic activation. Evident cytotoxicity was observed in Experiment I at concentrations ≥1.0 mM in the absence of metabolic activation. In Experiment II, marked cytotoxicity was recorded at concentrations of 2.0 and 6.0 mM in the presence of metabolic activation and at concentrations ≥0.10 mM in the absence of metabolic activation. The vehicle controls had acceptable mutant frequency values that were within the normal range for the L5l78Y cell line at the TK locus. The positive control materials induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system. The test material did not induce any biologically relevant increase in the mutant frequency at any dose level in any of the exposure groups. Additionally, in Experiments I and II colony sizing showed no clastogenic effects induced by the test item under the experimental conditions (with and without metabolic activation). Thus, the test material was considered to be non-mutagenic or clastogenic to L5178Y cells under the conditions of the test.
Based on the available data on genetic toxicity in vitro with the read-across substances hexadecyltrimethoxysilane (CAS 16415-12-6) and triethoxyoctylsilane (CAS 2943-75-1) sufficient evidence is available to conclude that the registration substance triethoxyhexadecylsilane (CAS 16415-13-7) is neither mutagenic in bacterial and mammalian cells nor clastogenic in mammalian cells.
Justification for classification or non-classification
Reliable data from a structural analogue and the registration substance on genetic toxicity indicate that Triethoxyhexadecylsilane do not meet the criteria for classification according to Regulation (EC) No 1272/2008, and the available data are therefore conclusive but not sufficient for classification.
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