Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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: - | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames assay:
The test substance did not induce gene mutation in Salmonella typhimurium strains TA1535, TA1537, TA1538, TA100 and TA98 in the presence and absence of S9 metabolic activation system by plate-incorporation assay and hence is not likely to classify as a gene mutant in vitro.
In vitro mammalian chromosome aberration study:
The test chemical did not induce chromosome aberrations in the mammalian cell line in the presence and absence of S9 metabolic activation system and hence it is not mutagenic in the chromosome aberration study performed.
In vitro gene mutation study in mammalian cells:
Test chemical did not induce mutation in mammalian cell line in the presence and absence of metabolic activation and hence it is not likely to classify as a gene mutant in vitro.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
- Specific details on test material used for the study:
- Not specified
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- Not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 metabolic activation
- Test concentrations with justification for top dose:
- 0.1 to 4.0 mg/ml without S9; 2.0 to 5.0 mg/ml with S9 activation
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- N-dimethylnitrosamine
- methylmethanesulfonate
- Details on test system and experimental conditions:
- Dose Selection - Appropriate concentrations for mutagenicity testing were determined by preliminary measurements of cytotoxicity to CHO cells of a range of concentrations tested both in the presence and absence of a rat-liver S9 metabolic activation system. Selection of a suitable range of concentrations for testing was based upon an estimate of the doses which would not produce excessive cytotoxicity to the treated cells. Dimethylsulfoxide (DMSO) was used as the solvent for dilutions. All dilutions were prepared immediately prior to testing.
Test Procedure - Duplicate cultures of CHO cells were exposed for 5 hours to a minimum of five concentrations of Organofunctional Silane A-1120 in test both with and without the addition of a rat-liver S9 metabolic activation system. Various dose levels of Organofunctional Silane A-1120 for testing were attained by direct addition of various aliquots of the diluted test agent into the cell culture medium. The surviving fraction was determined at 18 to 24 hours after the removal of the test chemical using 4 plates/culture and 100 cells/plate. The mutant fraction was determined after a 9 to 12 day sub-culturing period to allow "expression" of the mutant phenotype. The mutant fraction was assessed in selective medium with 2 x 10E5 cells/plate in 5 plates/dosed culture (i.e. 1 x 10E6 total cells/dosed culture). The plating efficiency of these cells was assessed in non-selective medium using 4 plates/dosed culture with 100 cells/plate. The mutagenicity/survival/plating efficiency data from at least the top five concentrations which allowed sufficient cell survival for assessment of survival and quantification of mutants were recorded. The percentage of cells surviving the treatment, the numbers of mutant colonies, the percentage of clonable cells and the calculated number of mutants/10E6 clonable cells were presented. Positive (dimethylnitrosamine with S9 activation and ethylmethanesulfonate without S9 activation) and vehicle control (cell culture medium and DMSO) materials were tested concurrently to assure both the sensitivity of the test system. - Statistics:
- The data were analyzed in comparison to concurrent control values after transformation of the mutation frequencies (MF) and SCE values according to the conversion method of Box and Cox (1964). This procedure for CHO data follows procedures described by Snee and Irr: (MF + 1)^0.15 (Snee, R.D. and J.D. Irr, Mutation Research, 85 (1981), 77-93). Data for positive and negative controls were compared to historical ranges but were not analyzed statistically.
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 6 mg/ml and higher in tests with and without S9 activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: No mutagenic potential was observed
- Conclusions:
- The test substance did not induce any statistical significant increase in the number of cells in the presence or absence of the S9 metabolic activation. Hence, the test substance can be considered to be non-mutagenic.
- Executive summary:
The test chemical was assayed for gene mutations in the Chinese Hamster Ovary (CHO) cells both in the absence and presence of S9 metabolic activation. Positive (dimethylnitrosamine with S9 activation and ethylmethanesulfonate without S9 activation) and vehicle control (cell culture medium and DMSO) materials were tested concurrently to assure both the sensitivity of the test system. The study was performed according to OECD 476 Guidelines. The test concentrations used were- 0.1 to 4.0 mg/ml without S9 metabolic activation and 2.0 to 5.0 mg/ml with S9 activation. did not product any statistically significant increases in the incidence of mutations of CHO cells within a range of cytotoxic-to-noncytotoxic concentrations between 2.5 to 4.0 mg/ml in tests without an S9 metabolic activation system. With S9 activation, one intermediate dose of 2.5 mg/ml produced a mutant incidence in one of the two dosed cultures which was statistically greater than the concurrent controls. No dose-related trend in mutant values was observed in the test with or without S9 activation. The biological significance of the single increase was evaluated by determining reproducibility in an independent repeat test over a narrower range of concentrations with S9 activation. No significant or dose-related increases were observed in the repeat test. The test substance did not induce any statistical significant increase in the number of cells in the presence or absence of the S9 metabolic activation. Hence, the test substance can be considered to be non-mutagenic.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- In vitro mammalian chromosomal aberration test was performed to determine the mutagenic nature of the test chemical
- GLP compliance:
- not specified
- Type of assay:
- other: In vitro mammalian chromosomal aberration test
- Target gene:
- No data
- Species / strain / cell type:
- mammalian cell line, other: A pseudo-diploid Chinese hamster cell line (Don)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Eagle's minimum essential medium supplemented with 10% fetal calf serum (pH 7.2) adjusted by HEPES6 buffer
- Properly maintained: Yes
- Periodically checked for Mycoplasma contamination: Yes
- Periodically checked for karyotype stability: Yes, CHL cells had modal chromosome numbers of 21 and 25
- Periodically "cleansed" against high spontaneous background: No data - Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S-9 induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 0, 0.000001, 0.00001, 0.0001 or 0.001 M
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
Cells at the start of seeding: 1.0-1.2 X 106 cells per TD-40 culture bottle
DURATION
- Preincubation period: No data
- Exposure duration: 26 hrs
- Expression time (cells in growth medium): 26 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): aqueous solution of 33258 Hoechst and Giemsa
NUMBER OF REPLICATIONS: Duplicate
NUMBER OF CELLS EVALUATED: 100 metaphase plates for each dose
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Yes, mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: The chromosome slide was stained in aqueous solution of 33258 Hoechst for 10 minutes, rinsed briefly in tap water, and mounted in phosphate buffer (pH 7.0) with a cover slip. The slide was exposed to an electric light (60 W, at 12-cm distance) for 1 hour. The cover slip was removed by tap water, and the slide was incubated in 1 M NaH2P04 (pH 8.0, 83-85° C) for 10 minutes, rinsed, and stained in 2.5% Giemsa (in phosphate buffer, 0.07 M, pH 7.0) for 5 minutes. Conventional Giemsa-stained slides were also prepared for scanning of chromosome aberrations. - Rationale for test conditions:
- No data
- Evaluation criteria:
- The frequency of aberrations, excluding gaps, was indicated by the number of breaks per cell. A ring, a dicentric, and a chromatid exchange were each scored as two breaks, a tricentric as four breaks, and an acentric fragment or an isochromatid break as one break.
- Statistics:
- No data
- Species / strain:
- mammalian cell line, other: CHL
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 0.00001 and 0.0001 M
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data
- Remarks on result:
- other: No mutagenic potential
- Conclusions:
- The test chemical did not induce chromosome aberration in pseudo-diploid Chinese hamster cell line (Don) and hence it is not likely to classify as a gene mutant in vitro.
- Executive summary:
In vitro mammalian chromosomal aberration test was performed to determine the mutagenic nature of the test chemical. The test chemical was mixed with DMSO and used at dose level of 0, 0.000001, 0.00001, 0.000, or 0.001 M using pseudo-diploid Chinese hamster cell line (Don). Three hours after 1.0-1.2 X 106 cells per TD-40 culture bottle were seeded, BUdR (1µg/ml) and test chemical was added to the cultures under an ordinary yellow darkroom safety lamp. Concurrent solvent control was also included in the study. All cultures were kept in complete darkness at 37° C for 26 hours (this covered two rounds of cell cycle), and 0.25µg colchicine/ml was added for the final 2 hours. The cells were collected by scraping them with a rubber policeman and prepared air-dried slides following hypotonic treatment and fixation in ice-cold methanol: acetic acid (3: 1). The chromosome slide was stained in aqueous solution of 33258 Hoechst for 10 minutes, rinsed briefly in tap water, and mounted in phosphate buffer (pH 7.0) with a cover slip. The slide was exposed to an electric light (60 W, at 12-cm distance) for 1 hour. The cover slip was removed by tap water, and the slide was incubated in 1 M NaH2P04 (pH 8.0, 83-85° C) for 10 minutes, rinsed, and stained in 2.5% Giemsa (in phosphate buffer, 0.07 M, pH 7.0) for 5 minutes. Conventional Giemsa-stained slides were also prepared for scanning of chromosome aberrations. The frequency of aberrations, excluding gaps, was indicated by the number of breaks per cell. A ring, a dicentric, and a chromatid exchange were each scored as two breaks, a tricentric as four breaks, and an acentric fragment or an isochromatid break as one break. The test chemical did not induce chromosome aberration in pseudo-diploid Chinese hamster cell line (Don) and hence it is not likely to classify as a gene mutant in vitro.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- weight of evidence
- Study period:
- Not specified
- Reliability:
- 4 (not assignable)
- Justification for type of information:
- Data was taken from secondary source
- Principles of method if other than guideline:
- Bacterial reverse mutation assay was carried out to determined the genetic toxicity of the given test chemical.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Not specified
- Target gene:
- Histidine operon (S. typhimurium strains); tryptophan operon (E. coli).
- Species / strain / cell type:
- other: Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1537
- Details on mammalian cell type (if applicable):
- Not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- Not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital and ß-Naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
0, 50, 160, 500, 1600 and 5000 µg/plate- Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- All active strains
- Untreated negative controls:
- no
- 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:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
TA 100, TA 1535 (without activation)- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
TA 98 (without activation)- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 72 hours
- Expression time (cells in growth medium): 72 hours
NUMBER OF REPLICATIONS: 3 plates per test concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; background lawn assessment - Rationale for test conditions:
- Not specified
- Evaluation criteria:
For a test compound 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. This 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. If however these increases do occur in both tests, this will be taken as an indication of mutagenic effect.- Statistics:
- Mean number of revertants per plate and the standard deviation around the mean were calculated.
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: >5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: >5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: >5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: >5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
COMPARISON WITH HISTORICAL CONTROL DATA: Numbers of spontaneous revertants were within acceptable range- Remarks on result:
- other: No mutagenic potential
- Conclusions:
- On the basis of the above mentioned study ,The test substance did not show any reproducible mutagenic activity in any of the strains tested up to limit concentrations with and without metabolic activation in either the plate incorporation or the repeat preincubation assay. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
- Executive summary:
In accordance with guideline OECD TG 471, a test of the genetic toxicity of 3-aminopropyl(triethoxy) (CAS number:919-30-2) was conducted using Salmonella typhimurium strains TA 98, TA 100, TA 1535, and TA 1537 The test substance did not show any reproducible mutagenic activity in any of the strains tested up to limit concentrations with and without metabolic activation in either the plate incorporation or the repeat preincubation assay. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- supporting study
- Study period:
- Not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data was taken from secondary source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Bacterial Reverse Mutation Assay was carried out for the RA chemical
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Not specified
- Target gene:
- Histidine operon (S. typhimurium strains); tryptophan operon (E. coli).
- Species / strain / cell type:
- other: S. typhimurium, other: TA97, TA98 and TA100
- Details on mammalian cell type (if applicable):
- Not specified
- Additional strain / cell type characteristics:
- other: Not specified
- Cytokinesis block (if used):
- Not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
Aroclor 1254 induced rat liver S9- Test concentrations with justification for top dose:
- 8, 40, 200, 1000 and 5000 µg/plate
- Vehicle / solvent:
- Ethylene glycol dimethyl ether (EGDME)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
TA100 without metabolic activation 100 µg/plate- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
TA1535 without metabolic activation 10000 µg/plate- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
TA1537 without metabolic activation 50 µg/plate- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98, TA1538 without metabolic activation 1 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: five replicates
DETERMINATION OF CYTOTOXICITY
- Method: condition of background lawn - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- Not specified
- Statistics:
- Not specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No mutagenic potential was observed in any strain at any dose concentration
- Remarks on result:
- other: No mutagenic potential was observed in any strain at any dose concentration
- Conclusions:
N-(3-(trimethoxysilyl)propyl)ethylenediamine has been tested for mutagenicity to bacteria in a study which was conducted according to OECD 471 but did not include TA102 or E.coli, compliant with GLP. No evidence of a test substance related increase in the number of revertants was observed with or without activation in the experiment. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.- Executive summary:
Genetic toxicity study as per OECD guideline 471 (Bacterial Reverse Mutation Assay) was carried out for the RA chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS number 1760-24-3).
During this test various strains were used TA98, TA100, TA1535, TA1537, and TA1538 at a dose range of 8, 40, 200, 1000 and 5000 µg/plate at metabolic activation factor Aroclor 1254 induced rat liver S9. Positive control substances are used methylmethanesulfonate,2-nitrofluorene,9-aminoacridine, and ethylmethanesulphonate by using the agar plate method.
After a complete analysis of the results the RA chemical which is structurally similar to test chemical
N-(3-(trimethoxysilyl)propyl)ethylenediamine has been tested for mutagenicity to bacteria in a study which was conducted according to OECD 471 but did not include TA102 or E.coli, compliant with GLP. No evidence of a test substance related increase in the number of revertants was observed with or without activation in the experiment. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- weight of evidence
- Study period:
- Not Specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data was taken from secondary source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
bacterial reverse mutation assay- Principles of method if other than guideline:
- Bacterial muation test was carried out for the test chemical
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Not Specified
- Target gene:
- Histidine operon (S. typhimurium strains); tryptophan operon (E. coli).
- Species / strain / cell type:
- other: TA98, TA100, TA1535, TA1537 and TA1538
- Details on mammalian cell type (if applicable):
- Not Specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- With metabolic activation: slight cytotoxicity in all strains at 2.5 and 5
mg/plate; Without metabolic activation: slight cytotoxicity in all strains at
2.5 and 5 mg/plate - Metabolic activation:
- with and without
- Metabolic activation system:
Aroclor 1254 induced rat liver S9- Test concentrations with justification for top dose:
- 0.1, 0.5, 1, 2.5 and 5 µg/plate
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
TA100 without metabolic activation 100 µg/plate- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- TA1535 without metabolic activation 10000 µg/plate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
TA1537 without metabolic activation 50 µg/plate- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98, TA1538 without metabolic activation 1 µg/plate
- Details on test system and experimental conditions:
- Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: triplicate plates, experiment repeated
DETERMINATION OF CYTOTOXICITY
- Method: other: condition of background lawn - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- Not specified
- Statistics:
- Not specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No mutagenic potential was observed in any strain at any dose concentration
- Remarks on result:
- other: No mutagenic potential was observed in any strain at any dose concentration
- Conclusions:
- N-(3-(trimethoxysilyl)propyl)ethylenediamine has been tested for mutagenicity to bacteria, in a study which was conducted according to OECD 471, compliant with GLP. No evidence of a test substance related increase in the number of revertants was observed with or without metabolic activation in the initial or repeat experiment. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
- Executive summary:
Genetic toxicity study as per OECD guideline 471 (Bacterial Reverse Mutation Assay) was carried out for the RA chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS number 1760-24-3).
During this test various strains were used TA98, TA100, TA1535, TA1537, and TA1538 at a dose range of 0.1, 0.5, 1, 2.5, and 5 µg/plate at metabolic activation factor Aroclor 1254 induced rat liver S9. Positive control substances are used methylmethanesulfonate,2-nitrofluorene,9-aminoacridine, and ethylmethanesulphonate by using the agar plate method.
After a complete analysis of the results the RA chemical which is structurally similar to test chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine has been tested for mutagenicity to bacteria, in a study which was conducted according to OECD 471, compliant with GLP. No evidence of a test substance-related increase in the number of revertants was observed with or without metabolic activation in the initial or repeat experiment. It is concluded that the substance is negative for mutagenicity to bacteria under the conditions of the test.
Referenceopen allclose all
Table: Frequencies of chromosome aberrations in Don cells after treatment with BUdR and solvent
Treatment |
No. of cultures |
No. of cultures observed for |
Breaks/cell |
|
Mean±SE |
Range |
|||
BUdR + DMSO |
6 |
600 |
0.0666±0.0010 |
0.02- 0.11 |
TABLE 2. Chromosome aberrations in Don cells exposed to chemical
Chemical |
Dose (M) |
MI |
Breaks/cell |
Test chemical |
0.000001 |
- |
0.02 |
0.00001 |
- |
0.09 |
|
0.0001 |
+ |
0.03 |
|
0.001 |
++ |
- |
| TA98 | TA100 | TA1535 | ||||||
Conc. | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic |
0* | 14 | 30 | No | 139 | 151 | No | 8 | 9 | No |
50 | 16 | 37 | No | 147 | 144 | No | 8 | 11 | No |
160 | 16 | 28 | No | 138 | 143 | No | 8 | 10 | No |
500 | 14 | 29 | No | 136 | 150 | No | 11 | 9 | No |
1600 | 22 | 41 | No | 136 | 150 | No | 9 | 13 | No |
5000 | 21 | 27 | No | 10 | 171 | Yes | 10 | 9 | No |
Positive Control | 104.2 | 1490 | No | 536 | 1592 | No | 316 | 153 | No |
Table 2a: Experiment 1 Plate incorporation assay Number of revertants per plate (mean of 3 plates) *solvent control with DMSO
Table 2b: Experiment 1 Plate incorporation assay Number of revertants per plate (mean of 3 plates)
| TA1537 | ||
Conc. | — MA | + MA | Cytotoxic |
0* | 5 | 13 | No |
50 | 0 | 11 | No |
160 | 2 | 15 | No |
500 | 2 | 10 | No |
1600 | 2 | 9 | No |
5000 | 0 | 3 | Yes |
Positive Control | 84 | 109 | No |
*solvent control with DMSO
Table 3a: Experiment 2 Pre incubation assay Number of revertants per plate (mean of 3 plates)
| TA98 | TA100 | TA1535 | ||||||
Conc. | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic | — MA | + MA | Cytotoxic |
0* | 19 | 25 | No | 121 | 116 | No | 12 | 9 | No |
250 | 21 | 25 | No | 97 | 102 | No | 7 | 11 | No |
500 | 20 | 30 | No | 98 | 91 | No | 13 | 11 | No |
1000 | 17 | 32 | No | 100 | 99 | No | 11 | 15 | No |
2000 | 18 | 31 | No | 101 | 110 | No | 8 | 10 | No |
4000 | 16 | 30 | No | 100 | 103 | No | 9 | 14 | No |
Positive Control | 103 | 1628 | No | 608 | 1384 | No | 341 | 216 | No |
*solvent control with DMSO
Table 3b: Experiment 2 Pre incubation assay Number of revertants per plate (mean of 3 plates)
| TA1537 | ||
Conc. | — MA | + MA | Cytotoxic |
0* | 15 | 16 | No |
250 | 17 | 10 | No |
500 | 17 | 13 | No |
1000 | 17 | 15 | No |
2000 | 13 | 15 | No |
4000 | 12 | 13 | No |
Positive Control | 263 | 131 | No |
*solvent control with DMSO
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Ames assay:
Study 1: Genetic toxicity study as per OECD guideline 471 (Bacterial Reverse Mutation Assay) was carried out for the RA chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS number 1760-24-3). During this test various strains were used TA98, TA100, TA1535, TA1537, and TA1538 at a dose range of 0.1, 0.5, 1, 2.5, and 5 µg/plate at metabolic activation factor Aroclor 1254 induced rat liver S9. Positive control substances are used methylmethanesulfonate,2-nitrofluorene,9-aminoacridine, and ethylmethanesulphonate by using the agar plate method. After a complete analysis of the results the RA chemical which is structurally similar to test chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine has been tested for mutagenicity to bacteria, in a study which was conducted according to OECD 471, compliant with GLP. No evidence of a test substance-related increase in the number of revertants was observed with or without metabolic activation in the initial or repeat experiment. It is concluded that the substance is negative for mutagenicity to bacteria under the conditions of the test.
Study 2: Genetic toxicity study as per OECD guideline 471 (Bacterial Reverse Mutation Assay) was carried out for the RA chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS number 1760-24-3). During this test various strains were used TA98, TA100, TA1535, TA1537, and TA1538 at a dose range of 8, 40, 200, 1000 and 5000 µg/plate at metabolic activation factor Aroclor 1254 induced rat liver S9. Positive control substances are used methylmethanesulfonate,2-nitrofluorene,9-aminoacridine, and ethylmethanesulphonate by using the agar plate method. After a complete analysis of the results the RA chemical which is structurally similar to test chemical N-(3-(trimethoxysilyl)propyl)ethylenediamine has been tested for mutagenicity to bacteria in a study which was conducted according to OECD 471 but did not include TA102 or E.coli, compliant with GLP. No evidence of a test substance related increase in the number of revertants was observed with or without activation in the experiment. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
Study 3: In accordance with guideline OECD TG 471, a test of the genetic toxicity of 3-aminopropyl(triethoxy) (CAS number:919-30-2) was conducted using Salmonella typhimurium strains TA 98, TA 100, TA 1535, and TA 1537 The test substance did not show any reproducible mutagenic activity in any of the strains tested up to limit concentrations with and without metabolic activation in either the plate incorporation or the repeat preincubation assay. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
In vitro mammalian chromosome aberration study:
In vitro mammalian chromosomal aberration test was performed to determine the mutagenic nature of the test chemical. The test chemical was mixed with DMSO and used at dose level of 0, 0.000001, 0.00001, 0.000, or 0.001 M using pseudo-diploid Chinese hamster cell line (Don). Three hours after 1.0-1.2 X 106 cells per TD-40 culture bottle were seeded, BUdR (1µg/ml) and test chemical was added to the cultures under an ordinary yellow darkroom safety lamp. Concurrent solvent control was also included in the study. All cultures were kept in complete darkness at 37° C for 26 hours (this covered two rounds of cell cycle), and 0.25µg colchicine/ml was added for the final 2 hours. The cells were collected by scraping them with a rubber policeman and prepared air-dried slides following hypotonic treatment and fixation in ice-cold methanol: acetic acid (3: 1). The chromosome slide was stained in aqueous solution of 33258 Hoechst for 10 minutes, rinsed briefly in tap water, and mounted in phosphate buffer (pH 7.0) with a cover slip. The slide was exposed to an electric light (60 W, at 12-cm distance) for 1 hour. The cover slip was removed by tap water, and the slide was incubated in 1 M NaH2P04 (pH 8.0, 83-85° C) for 10 minutes, rinsed, and stained in 2.5% Giemsa (in phosphate buffer, 0.07 M, pH 7.0) for 5 minutes. Conventional Giemsa-stained slides were also prepared for scanning of chromosome aberrations. The frequency of aberrations, excluding gaps, was indicated by the number of breaks per cell. A ring, a dicentric, and a chromatid exchange were each scored as two breaks, a tricentric as four breaks, and an acentric fragment or an isochromatid break as one break. The test chemical did not induce chromosome aberration in pseudo-diploid Chinese hamster cell line (Don) and hence it is not likely to classify as a gene mutant in vitro.
In vitro gene mutation study in mammalian cells:
The test chemical was assayed for gene mutations in the Chinese Hamster Ovary (CHO) cells both in the absence and presence of S9 metabolic activation. Positive (dimethylnitrosamine with S9 activation and ethylmethanesulfonate without S9 activation) and vehicle control (cell culture medium and DMSO) materials were tested concurrently to assure both the sensitivity of the test system. The study was performed according to OECD 476 Guidelines. The test concentrations used were- 0.1 to 4.0 mg/ml without S9 metabolic activation and 2.0 to 5.0 mg/ml with S9 activation. did not product any statistically significant increases in the incidence of mutations of CHO cells within a range of cytotoxic-to-noncytotoxic concentrations between 2.5 to 4.0 mg/ml in tests without an S9 metabolic activation system. With S9 activation, one intermediate dose of 2.5 mg/ml produced a mutant incidence in one of the two dosed cultures which was statistically greater than the concurrent controls. No dose-related trend in mutant values was observed in the test with or without S9 activation. The biological significance of the single increase was evaluated by determining reproducibility in an independent repeat test over a narrower range of concentrations with S9 activation. No significant or dose-related increases were observed in the repeat test. The test substance did not induce any statistical significant increase in the number of cells in the presence or absence of the S9 metabolic activation. Hence, the test substance can be considered to be non-mutagenic.
Justification for classification or non-classification
Based on all the available RA data it can be concluded that the given test chemical has structural similarity with the RA substance. It can be concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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.