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Diss Factsheets
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EC number: 224-221-9 | CAS number: 4253-34-3
- 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
There are no skin sensitisation studies available for the registered
substance itself.
In accordance with Column 2 of REACH Annex VII, the in vivo skin
sensitisation study (required in Annex VII Section 8.3) does not need to
be conducted as the available information indicates that the substance
meets the criteria for classification as corrosive to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2004-01-12 to 2004-02-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no reliability check reported
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Buehler test method. Furthermore, the LLNA test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan GmbH, Borchen, GERMANY
- Age at study initiation: not stated
- Weight at study initiation: 300-500g
- Housing: in groups in Terluran cages
- Diet: standard diet: ad libitum
- Water: drinking water ad libitum
- Acclimation period: described as adequate
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/-3
- Humidity (%): 55 +/-10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12h/ 12h
IN-LIFE DATES: From: To: not stated but within the period 2004-01-12 to 2004-02-13 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% for induction and challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% for induction and challenge
- No. of animals per dose:
- 20 test, 10 controls
- Details on study design:
- RANGE FINDING TESTS: 50% (in corn oil) and 100% tested on 2 animals for irritancy
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test groups: n=20
- Control group: n=10
- Site: left flank
- Frequency of applications: 3 applications at weekly intervals
- Duration: exposure duration 6h
- Concentrations: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the final induction
- Exposure period: 6h
- Test groups: n=20
- Control group: n=10
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 24 and 48h - Challenge controls:
- Negative but no concurrent positive control or reliability data provided. A reliability check was to be conducted in the future (BSL 040619).
- Positive control substance(s):
- no
- Remarks:
- reliability check was to be conducted in the future (BSL 040619)
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- no treatment
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- no treatment
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- other: not included
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- other: not included
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A well conducted, well reported Buehler sensitization test reported that a 100% concentration of the test material failed to induce a sensitization response in guinea pigs when challenged with the same neat test material. Appropriate concurrent negative controls were included, but the positive compliance test was to be undertaken at a later date.
Reference
No response was recorded at any time point in the test or control groups.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are no skin sensitisation studies available for methylsilanetriyl triacetate itself. However, two relevant in vivo skin sensitisation studies are available as supporting information. In the first test (BSL, 2004), a preparation containing a mixture of approximately 4.5% (total) methylsilanetriyl triacetate (described as triacetoxymethylsilane in the test report) and the related substance triacetoxyethylsilane was found to be not sensitising in a test conducted according to the Buehler method. In a second test (Hazelton Laboratories, 1990), a preparation containing approximately 5% methylsilanetriyl triacetate (described as triacetoxymethylsilane in the test report) was not sensitising, also using the Buehler method. These preparations are similar to products marketed for professional and consumer sealant applications and the studies therefore indicate that there is no sensitisation potential from use of the preparations.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on in vivo tests with preparations containing methylsilanetriyl triacetate, the registered substance is not classified for skin sensitisation under Regulation (EC) No 1272/2008.
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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