Registration Dossier
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EC number: 214-685-0 | CAS number: 1185-55-3
- 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
Description of key information
The key studies for skin and eye irritation were in vivo studies conducted in accordance with the appropriate test guidelines and GLP (Hazelton Labs, 1992 and Hoescht, 1991). Trimethoxy(methyl)silane was not irritant to rabbit skin or eyes, although mild effects were observed.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The key studies for skin and eye irritation were selected as the best available guideline studies, performed in compliance with GLP, and hence assigned Reliability 1.
The key study for skin irritation found the test material not irritating to rabbit skin in a test conducted in accordance with OECD 404 and in compliance with GLP (Hazleton, 1992). The study reports a mean erythema score (24/48/72 hours) of 0.11, with all effects fully reversible. A mean oedema score of 0 was also reported.
A supporting study for skin irritation was also available for review (Hazelton labs, 1966) which reports a primary dermal irritation index value of 0.66 in a study that was similar to OECD 404 with intact and abraded skin. The skin reactions observed do not meet the criteria for classification as a skin irritant in the EU.
A third study on skin irritation is also available, (Mellon Institute, 1963) in which the results were consistent with the other studies.
The key study for eye irritation found the test material non-irritating to the eyes of rabbits, in a study conducted in accordance with OECD 405 and in compliance with GLP (Hoechst, 1991). Mild to moderate conjunctival redness and discharge were observed in all test animals 1 hour post-instillation. Mild chemosis was also observed at this time point. All effects were fully resolved by the 24-hour observation.
A supporting study by the Mellon Institute (1963) was also available, reporting Grade 2 corneal necrosis determined according to a protocol which was lacking in detail on the study conduct, and was not compliant with GLP, using an excess amount of test material.
A second supporting study found the test substance slightly irritating in a reliable study conducted according to an appropriate test protocol, but not compliant with GLP (Hazelton Labs, 1966). The observed effects do not meet the criteria for classification as an eye irritant in the EU.
Finally, a reliability 4 supporting study was also available
which found the test material slightly irritating, but which does not meet current guideline requirements (Laboratoires de Recherches de la Societe des Usines Chimiques Rhone-Poulenc, 1972). The result does, however, add to the weight of evidence for eye irritation. The observed effects do not meet the criteria for classification as an eye irritant in the EU.
Justification for classification or non-classification
Based on the available data trimethoxy(methyl)silane does not require classification for irritation according to Regulation (EC) No 1272/2008.
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