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EC number: 217-982-3 | CAS number: 2031-62-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Sep 1991 - 16 Jun 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline, and in compliance with GLP. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- ; no info on when sensitivity test was done - OECD 406 states that should be done every 6 months.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed in 1992 when the OECD Guideline 406 adopted in 1992 was the current version. According to this guideline "the Guinea Pig Maximisation Test (GPMT) [...] and the non-adjuvant Buehler Test are given preference over other methods.“
Test material
- Reference substance name:
- Triethoxy(methyl)silane
- EC Number:
- 217-983-9
- EC Name:
- Triethoxy(methyl)silane
- Cas Number:
- 2031-67-6
- Molecular formula:
- C7H18O3Si
- IUPAC Name:
- triethoxy(methyl)silane
- Details on test material:
- - Name of test material (as cited in study report): Silan M1-triethoxy
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: Not clear, but stated that administered within 4 hours of preparation
- Storage condition of test material: About 4oC, in the dark and away from humidity
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Iffa- Credo (69592 L'Arbresle Cedex - France), Elevage Lebeau (78950 Gambais - France), Interfauna (37600 Loches - France), Charles River France.
- Age at study initiation: 'young' adult
- Weight at study initiation: 300 - 500 g
- Housing: by sex and in groups of five or six (2 for preliminary studies), in polystyrene cages with perforated flooring.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: At least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16 Sep 1991 to 16 Jun 1992
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Sterile Codex liquid paraffin
- Concentration / amount:
- intradermal induction: 25%
topical induction: 50% - Day(s)/duration:
- 48 hr for topical exposure
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sterile Codex liquid paraffin
- Concentration / amount:
- 10%
- Day(s)/duration:
- 24 hr
- No. of animals per dose:
- 20 (test group), 20 (control group)
- Details on study design:
- RANGE FINDING TESTS: 0.1 ml intradermal injection of 50, 25 and 10% was administered to the dorsal region in order to determine the concentration that will provoke a weak to moderate irritation and which is not toxic. The skin was evaluated at each concentration at 24 and 48 hours after the injections, according to the scale of Magnusson and Klingman. For the topical application a 48 hour occlusive patch test was performed with 50 and 25%. The aim of the topical applications is to determine the concentration that will provoke a weak to moderate irritation and which is non-toxic. The skin was evaluated at each concentration at 24 and 48 hours after the injections, according to the scale of Magnusson and Kligman. To determine the challenge concentration a 0.5 ml topical application of the test substance was applied using a 24 hour occlusive patch test in order to determine the maximum non-irritating concentration. The treated skin was evaluated at 24 and 48 hours after removal of the patches according to the above mentioned scale.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal: (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FCA/ isotonic injectable solution
Injection 2: test substance in a 25% (v/v) solution in Sterile Codex liquid paraffin
Injection 3: test substance in a 1:1 mixture (v/v) FCA/ isotonic injectable solution
Epicutaneous: test substance in a solution in Sterile Codex liquid paraffin
- Control group:
Intradermal: (3 pairs of injections)
Injection 1: a 1:1 mixture (v/v) FCA/ isotonic injectable solution
Injection 2: Sterile Codex liquid paraffin
Injection 3: Sterile Codex liquid paraffin at 50% (v/v) in a 1:1 mixture (v/v) FCA/ isotonic injectable solution
Epicutaneous: Sterile Codex liquid paraffin
- Site: dorsal shoulder region
- Frequency of applications: every 7 days
- Duration: Example: Days 0-8
- Concentrations: 25% solution (weak to moderate irritation in preliminary study)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Test and control groups: test substance and vehicle only
- Control group: test substance and vehicle only
- Site: clipped and shaved flank
- Concentrations: 10% - Evaluation (hr after challenge): 24 and 48 h
OTHER: Histopathological examinations of the skin were performed for three animals of the treated group which showed doubtful macroscopic reactions at 48 hours. - Challenge controls:
- The control group is actually a challenge control.
- Positive control substance(s):
- no
- Remarks:
- Sensitivity test conducted (no date)
Results and discussion
- Positive control results:
- No positive controls. However, it appears that the laboratory had conducted the same protocol with reference substances to show the sensitivity of their methodology.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema or edema in any animal. Mild desquamation at test substance site at 24 and 48 hour readings (observed in more males than females).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Induction: 0%; challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema or edema in any animal. Mild desquamation at test substance site at 24 and 48 hour readings (observed in more males than females).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- Induction: 25%; challenge: 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No erythema and edema in any animal. Desquamation in one animal.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- Induction: 25%; challenge: 10%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- No erythema/edema in males, Grade 1 erythema/edema in three females, where subsequent histopathology revealed no signs of cell mediated delayed hypersensitivity. 7/10 males and 4/10 females showed desquamation (including the three with erythema/edema).
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- but referred to regular positive testing in the laboratory
Any other information on results incl. tables
Signs of irritation were noted during the induction. Although macroscopic examination showed grade 1 erythema/edema in 3 females 48 h after challenge subsequent histopathological examinations did not reveal any lesion of delayed hypersensitivity in the those animals. No noticeable cutaneous abnormality was noted in the 20 guinea pigs examined in the control group.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
- Conclusions:
- In a guinea pig skin sensitisation study (guinea pig maximisation test) conducted to OECD 406 and to GLP the test material did not induce any skin sensitization in any of the animals tested at any time point. There were no clinical signs of systemic toxicity.
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