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EC number: 201-083-8 | CAS number: 78-10-4
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992/11/02 to 1993/01/19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The restriction was a reduced number of test animals.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Specified as OECD Test Guideline 406, as updated 1987/02. Current version adopted 1992/07/17.
- Deviations:
- yes
- Remarks:
- Only 10 test animals; guideline requires 20, and details of the laboratory control not presented in the report.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The available test was conducted in 1993, prior to the availabiliity of a validated test guideline for the LLNA (OECD Test Guideline 429)
Test material
- Reference substance name:
- Tetraethyl orthosilicate
- EC Number:
- 201-083-8
- EC Name:
- Tetraethyl orthosilicate
- Cas Number:
- 78-10-4
- Molecular formula:
- C8H20O4Si
- IUPAC Name:
- tetraethyl orthosilicate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Pirbright White, [Bor]: DHPW (SPF)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Co., 4799 Borchen
- Age at study initiation: "Young"
- Weight at study initiation: 424±23 g
- Housing: Conventional, maximum of 5 per Macrolon cage Type IV
- Diet (e.g. ad libitum): "Ssniff G 4," ad libitum
- Water (e.g. ad libitum): Municipal water, ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 03.11.1992 to 10.12.1992
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: MEH 56 corn oil
- Concentration / amount:
- 100% for first two inductions and 50% for third induction
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: MEH 56 corn oil
- Concentration / amount:
- 50% for challenge
- No. of animals per dose:
- 10F
- Details on study design:
- RANGE FINDING TESTS: Gauze sponges measuring 2cm x 2cm were each coated with about 0.4 g of tetraethyl orthosilicate in MEH 56 corn oil at concentrations of 2.5, 25, 50 or 100% and applied to the shaved flank area. MEH 56 corn oil as control was applied to the shoulder or thigh. Each gauze was covered with an occlusive dressing and held in place for 6 hours by bandage. After removal of the patch, the remaining substance was removed using corn oil and a cellulose swab. The dermal reaction was evaluated immediately after patch removal and again at 24 and 48 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 100 % tetraethyl orthosilicate for inductions 1 and 2, and 50% for induction 3.
- Control group: MEH 56 corn oil
- Site: Left flank
- Frequency of applications: Day 0, day 7, day 14
- Evaluation (hours after challenge): 6 and 24, after bandage removal.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 28
- Exposure period: 6 hours
- Test groups: tetraethyl orthosilicate
- Control group: MEH 56 corn oil
- Site: Right flank
- Concentrations: 50%
- Evaluation (hours after challenge): 6, 24, 48 and 72 after bandage removal.
C. OTHER EVALUATIONS
- Body weight: Day 0, once a week, and at study end, in tetraethyl orthosilicate and MEH 56 corn oil groups
- Systemic effects: Recorded, in tetraethyl orthosilicate and MEH 56 corn oil groups - Challenge controls:
- Negative control was MEH 56 corn oil.
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive control.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no test substance-related systemic or body weight effects
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- at 24, 48, or 72 hr
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no test substance-related systemic or body weight effects
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- at 24, 48, or 72 hr
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- at 24, 48, or 72 hr
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- at 24, 48, or 72 hr
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Remarks on result:
- other: no positive control included
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- other: no positive control included
Any other information on results incl. tables
There were no test substance-related effects or influence on body weight in either the tetraethyl orthosilicate or MEH corn oil control animals. Very light erythema was observed for tetraethyl orthosilicate in 2 of 10 animals during Induction Phase I (at 24 hours), and in 3 of 10 animals in Induction Phase II (at 24 hours). Two (2) of the 3 animals with erythema in Induction Phase II also had very light edema. There was no skin irritation observed for the tetraethyl orthosilicate in Induction Phase III (at 24 hours) or in the Challenge Phase (at 24, 48 and 72 hours). No skin irritation was observed in the MEH corn oil control animals either during induction (at 24 hours) or challenge (24, 48, and 72 hours).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the key skin sensitisation study (Buehler test; reliability score 2) conducted according to OECD Test Guideline 406 (non-LLNA, prior to LLNA OECD Test Guideline 429) and incompliance with GLP, tetraethyl orthosilicate was not sensitising to the skin of guinea pigs.
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