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EC number: 242-560-0 | CAS number: 18765-38-3
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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:
- no
- 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.
Test material
- Reference substance name:
- Tetrakis(2-butoxyethyl) orthosilicate
- EC Number:
- 242-560-0
- EC Name:
- Tetrakis(2-butoxyethyl) orthosilicate
- Cas Number:
- 18765-38-3
- Molecular formula:
- C24H52O8Si
- IUPAC Name:
- tetrakis(2-butoxyethyl) orthosilicate
- Details on test material:
- - Name of test material (as cited in study report): Dynasil BG
- Substance type: Organosilane
- Physical state: Liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann
- Age at study initiation: no data
- Weight at study initiation: 429-491 g
- Housing: no data
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction phase 1: neat
Induction phase 2 (day 7): neat
Induction phase 3 (day 14): 50% in corn oil
Challenge: 50% in corn oil
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Induction phase 1: neat
Induction phase 2 (day 7): neat
Induction phase 3 (day 14): 50% in corn oil
Challenge: 50% in corn oil
- No. of animals per dose:
- Ten
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three
- Exposure period: Six hours
- Test groups: test substance only
- Control group: Corn oil
- Site: Left flank
- Frequency of applications: 0, 7 and 14 days
- Concentrations: neat
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: day 28
- Exposure period: Six hours
- Control group: Corn oil
- Site: Right flank
- Concentrations: 50% in corn oil
- Evaluation (hr after challenge): 24, 48 and 72 - Challenge controls:
- Corn oil negative controls only
- Positive control substance(s):
- not required
Results and discussion
- Positive control results:
- No positive controls
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 12
- Group:
- test chemical
- Dose level:
- 50% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical observations
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical observations
- Remarks on result:
- no indication of skin sensitisation
- 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
- 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
- Group:
- positive control
- Remarks on result:
- other: positive control readings were not included
Any other information on results incl. tables
In induction phase 1, no skin reactions were evident at six hours post-exposure, but by 24 hours 3/10 animals had grade 1 erythema, and no oedema. In induction phase 2, there were no skin reactions by six hours, but by 24 hours 4/10 and 3/10 animals had grade 1 erythema and oedema, respectively. In phase 3 induction, 4/10 animals had erythema and 2/10 animals had oedema by six hours, but there was no evidence of a reaction by 24 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material was not sensitising to the skin of guinea-pigs under the conditions of this good quality OECD 406 study, conducted to GLP.
- Executive summary:
Ten test and ten control (corn oil only) Dunkin-Hartley guinea-pigs were used in this OECD 406 Buehler test. Following three six-hour induction phases (using 100% test material in phases 1 and 2, and 50% in corn oil in phase 3) on the left flanks of the animals, the challenge phase involved a six-hour induction phase on the right flanks of the animals. During the induction phases there was mild irritation in some animals. None of the guinea-pigs showed any skin reactions in the challenge phase and hence the substance was concluded not to be a skin sensitiser.
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