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EC number: 221-334-5 | CAS number: 3069-25-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Genetic toxicity in vitro:
Bacterial mutagenicity (Ames test, OECD 471, WoE): S. typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 102 and E. coli WP2: negative with and without metabolic activation (RA from CAS 1760-24-3 and CAS 227085-51-0)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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 applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- 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 applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli, other: E. coli WP2 pKM101 (CM881)
- 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 valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. I: at 5000 µg/plate without S9-mix (TA 98, TA 102, TA 1535, TA 1537); Exp. II: ≥2500 µg/plate without S9-mix (TA 98, TA 100, TA 102)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: CAS 1760-24-3
- Remarks:
- Huntingdon Life Sciences 1999
- Conclusions:
- CAS 1760-24-3 and CAS 227085-51-0 were not mutagenic in an Ames test. As explained in the analogue justification, the differences in molecular structure between the target and the source are unlikely to lead to differences in genetic toxicity. Thus, N-Methylaminopropyltrimethoxysilane is considered to be non-mutagenic in bacteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
No data on genetic toxicity in vitro is available with N-methyl-3-(trimethoxysilyl)propylamine (CAS 3069-25-8). Therefore, read across from the structurally similar source substances N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3) and N-ethyl-3-trimethoxysilyl-2-methylpropanamine (CAS 227085-51-0) was applied. In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and in accordance with the Read across assessment framework (RAAF, ECHA 2017) read across from analogue substances has been applied to support the human health hazard assessment of N-methyl-3-(trimethoxysilyl)propylamine (CAS 3069-25-8).
Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
No measured data are available to assess the genotoxic potential in vitro of N-methyl-3-(trimethoxysilyl)propylamine (CAS 3069-25-8). However, reliable data are available for the source substances, N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3) and N-ethyl-3-trimethoxysilyl-2-methylpropanamine (CAS 227085-51-0). Both structural analogues were found to be not mutagenic to bacteria. The substances are all structural analogues and have similar silicon containing hydrolysis products and therefore read-across to the target substance is appropriate. The other hydrolysis product methanol is not genotoxic.
Genetic toxicity (mutagenicity) in bacteria in vitro
A reliable bacterial gene mutation study (Ames test) performed according to an appropriate US EPA test guideline that is equivalent to OECD 471 and in compliance with GLP with N-(3-(trimethoxysilyl)propyl)ethylenediamine (CAS 1760-24-3) is available (Huntingdon Life Science, 1999). The strains Salmonella typhimurium TA 1535, TA 1537, TA 98 and TA 100 as well as the E. coli strains E. coli WP2 uvrA and E. coli WP2 were tested according to the plate incorporation (experiment I) and pre-incubation (experiment II) 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 50 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. Appropriate solvent (water) 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 471 and in compliance with GLP with N-ethyl-3-trimethoxysilyl-2-methylpropanamine (CAS 227085-51-0) is available (RCC, 2001a). The strains Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 were tested according to the plate incorporation (experiment I) and pre-incubation (experiment II) procedure in the absence and presence of a metabolic activation system (phenobarbital and β-naphtholflavone-induced rat liver S9-mix). Two independent experiments were conducted in three repetitions at each concentration from 33 to 5000 µg/plate. Relevant toxic effects occurred in all strains except TA 100 in the first experiment at 5000 µg/plate without metabolic activation. In the second experiment substantial toxic effects were observed in strains TA 98, TA 100 and TA 102 at 2500 and 5000 µg/plate without metabolic activation. Appropriate solvent (DMSO) 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.
Justification for classification or non-classification
Based on the available data on genetic toxicity the registered substance is not considered to induce genetic toxicity in bacteria. However, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 can be made, as no information on chromosomal aberration and mutagenicity in mammalian cells/in vivo is available.
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.
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