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EC number: 813-152-5 | CAS number: 152261-44-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
REACH_data waiving based on momoner data | Ames test
REACH_negative | S. typhimurium TA98, TA100, TA1535, TA1537, TA1538 | reverse mutation assay | with and without | #WoE##Analogy#
REACH_negative | S. typhimurium, E. coli | Ames Test | with and without | #WoE##Analogy#
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- Monomer data:
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Qualifier:
- no guideline available
- Version / remarks:
- guideline not specified in the publication
- Principles of method if other than guideline:
- Salmonella typhimurium reverse mutation assay with and without metabolic activation
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 1-113 mg/plate
- Vehicle / solvent:
- not specified
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Remarks:
- no details given in the publication
- Details on test system and experimental conditions:
- no further details
- Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- There was no evidence for an increased mutation frequency either in the presence or absence of metabolic activation.
- Conclusions:
- Several in vitro genotoxicity studies have been conducted which showed that TEG is devoid of a mutagenic potential. A Salmonella typhimurium reverse mutation assay was executed with strains TA98, TA100, TA1535, TA1537 and TA1538 at a concentration range for TEG of 1–113 mg per plate in the presence and absence of a metabolic activation system. There was no evidence for an increased mutation frequency (Ballantyne and Snelligs, Appl. Toxicol. 27: 291–299, 2007).
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- not specified
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
- Qualifier:
- no guideline available
- Version / remarks:
- guideline not specified in the publication
- Principles of method if other than guideline:
- Ames Test
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: TA 97, TA 98, TA 100, TA 102, TA 1535, TA 1537, TA 1538
- Remarks:
- Ames Test
- Species / strain / cell type:
- S. typhimurium, other: TA 97, TA 98, TA 100, TA 104, TA 1535
- Remarks:
- Preincubation Assay
- Metabolic activation:
- not specified
- Metabolic activation system:
- Aroclor induced S9 mix (rat and syrian hamster)
- Test concentrations with justification for top dose:
- - Ames Test: up to 240 mg/plate
- Preincubation Assay: up to 10 mg/plate - Vehicle / solvent:
- not specified
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Remarks:
- no details given in the publication
- Details on test system and experimental conditions:
- no further details
- Key result
- Species / strain:
- S. typhimurium, other: TA 97, TA 98, TA 100, TA 102, TA 1535, TA 1537, TA 1538
- Remarks:
- Ames Test
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium, other: TA 97, TA 98, TA 100, TA 104, TA 1535
- Remarks:
- Preincubation Assay
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- - Ames Test: There was a weak but reproducible positive effect in TA 102 (less than 2-fold increase in revertants) but only at ethanol concentrations of 160 and 240 mg/plate. These concentrations are far excess of the generally accepted maximum concentration for routine testing (5 mg/plate; OECD, 1997, Guideline no. 471).
- Conclusions:
- The balance of evidence is that ethanol is not genotoxic in vitro. The results of bacterial mutagenicity assays have generally been negative for ethanol. Positive results are only found at ethanol concentrations higher than recommended for guideline testing. Ethanol is not therefore considered to be mutagenic in the Ames test (Phillips and Jenkinson, Mutagensis 16: 91-101, 2001).
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
Justification for classification or non-classification
Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine is the reaction mixture of 3-aminopropyltriethoxysilane (CAS 919-30-2) and triethylene glycol (CAS 112-27-6). 3-Aminopropyltriethoxysilane is known to hydrolyse to form silanols and ethanol (CAS 64-17-5). Silanols rapidly self-condense or condensate with triethylene glycol and/or water to form bridged and cyclic oligomers under formation of Si-O-Si bonds. Therefore, Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine comprises of various oligomeric structures based on 3-aminopropyltriethoxysilane, triethylene glycol and/or water. Triethylene glycol is the main component of Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine besides small amounts of ethanol. No free 3-aminopropyltriethoxysilane is detectable.
Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine is unstable upon contact with moisture. lt undergoes further condensation reactions that form highly polymerized poly silicic acids while liberating the triethylene glycol, that was initially bound to the oligomeric structures. The underlying chemistry is commonly known as sol-gel reaction (see Holleman, Arnold F., Lehrbuch der anorganischen Chemie/Holleman-Wiberg, 101. Auflage, de Gruyter, Berlin, New York 1995, page 924). The poly silicic acid moieties are not stable and prone to further condensation generating water insoluble, resinous polymers. The molecular weight of the resulting polymers is predicted to be over 1000.
Since 3-aminopropyltriethoxysilane is completely consumed into the developing polymer matrix, it is assumed that the toxicological profile of Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine will be mainly determined by triethylene glycol and to a lesser extent by ethanol.
Several in vitro genotoxicity studies have been conducted which showed that triethylene glycol is devoid of any mutagenic and clastogenic potential. Triethylene glycol did not show genotoxic effects in an Ames Test, an SOS-chromotest, a gene mutation study (HGPRT locus) and chromosome aberration study in Chinese hamster ovary cells as well as a sister chromatid exchange assay in Chinese hamster ovary cells (Ballantyne and Snelligs, Appl. Toxicol. 27: 291–299, 2007).
The balance of evidence is that ethanol is not genotoxic in vitro. The results of bacterial mutagenicity assays have generally been negative for ethanol. Positive results are only found at ethanol concentrations higher than recommended for guideline testing. Ethanol is not therefore considered to be mutagenic in the Ames test (Phillips and Jenkinson, Mutagenesis 16: 91-101, 2001).
3-Aminopropyltriethoxysilane has been submitted to several Ames assays, in vitro V79 hamster lung cell and Chinese hamster fibroblast chromosome aberration assays, two Chinese hamster ovary cell HGPRT gene mutation assays, and an in vivo mouse micronucleus assay. Existing in vitro studies have not revealed any evidence of genotoxic potential (OECD SIDS Initial Assessment Report, 3-aminopropyltriethoxysilane, 2003). Since these tests are executed under conditions, which lead to formation of silanols and other oligomeric structures, these compounds are covered as well.
Existing data on the precursors of Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine clearly show that testing would not yield positive results in an Ames study. Furthermore, Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine will react upon contact with water to form poly silicic acids by releasing triethylene glycol and ethanol. The chemically stable reaction product is water insoluble, highly polymerized and would therefore not exhibit mutagenic effects. For the aforementioned reasons testing of Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine in the Ames test is scientifically not required.
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