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EC number: 288-657-1 | CAS number: 85857-16-5
- 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:
- August to November 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because the 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:
- Trimethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
- EC Number:
- 288-657-1
- EC Name:
- Trimethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
- Cas Number:
- 85857-16-5
- Molecular formula:
- C11H13F13O3Si
- IUPAC Name:
- trimethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
- Reference substance name:
- [2-(Perfluorohexyl)ethyl]trimethoxysilane
- IUPAC Name:
- [2-(Perfluorohexyl)ethyl]trimethoxysilane
- Test material form:
- other: liquid
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Clr: HA
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 4 weeks
- Weight at study initiation: 302 - 347 g
- Housing: Terluran cages on Altromin saw fibre bedding
- Diet: Altromin 3122 maintenance diet ad libitum
- Water: tap water ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 33 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): at least 10 per hour
- Photoperiod (hrs dark / hrs light): 12:12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: suspended in acetone
- Concentration / amount:
- Preliminary test to evaluate the irritation threshold:
2 animals treated with concentrations of 100% or 50% of the test item suspended in acetone for 6 hours.
2 animals treated with a concentration of 75% of the test item suspended in acetone for 6 hours.
Induction phases I, II and III: a concentration of 100% of the test item suspended in acetone for 6 hours. The phases were at weekly intervals.
Challenge phase: a concentration of 50% of the test item suspended in acetone for 6 hours.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: suspended in acetone
- Concentration / amount:
- Preliminary test to evaluate the irritation threshold:
2 animals treated with concentrations of 100% or 50% of the test item suspended in acetone for 6 hours.
2 animals treated with a concentration of 75% of the test item suspended in acetone for 6 hours.
Induction phases I, II and III: a concentration of 100% of the test item suspended in acetone for 6 hours. The phases were at weekly intervals.
Challenge phase: a concentration of 50% of the test item suspended in acetone for 6 hours.
- No. of animals per dose:
- 4 animals in preliminary test, 20 animals in induction and challenge.
- Details on study design:
- RANGE FINDING TESTS:
2 animals were treated topically with 50% applied to right flank and 100% applied to left flank for 6 hours; 2 animals were treated topically with 75% applied to right and left flank for 6 hours. Irritation was evaluated.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: three
- Exposure period: 6 hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: left flank
- Frequency of applications: weekly
- Duration: weekly exposures for 3 weeks; challenge phase was initiated 14 days after the final induction.
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Exposure period: six hours
- Test groups: 20 animals
- Control group: 10 animals
- Site: right flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 hours after removal of patch. - Challenge controls:
- A reliability check was performed in May/June 2014. 20 animals were treated with 50% of the positive control substance in Vaseline in induction phases I, II and III; 20 animals were treated with 25% of the positive control substance in Vaseline in the challenge phase.
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole, purity >98%
Results and discussion
- Positive control results:
- 50% and 55% of the animals treated in the laboratory reliability check showed positive reactions at the 24 and 48 hour observations, respectively.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% suspension in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50% suspension in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Any other information on results incl. tables
Preliminary test: erythema grade 1 was observed at site of application in both animals treated for 6 hours with 100% test substance and both animals treated for 6 hours with 75% test substance. No erythema was observed in any animal at 48 and 72 hours. A concentration of 50% was found to be highest dose which did not cause any signs of irritation after 6 hours topical treatment and was chosen for the challenge application in the main test.
Induction: no sign of irritation was observed in any animal immediately after removal of patch. Erythema grade 1 was observed in 5/20 animals at Induction I, in 2/20 in induction II and 2/20 in induction III.
Challenge: neither erythema nor oedema was observed in any animal at any time of observation. There was no evidence of sensitisation and the percentage of sensitised animals was 0%.
Body weight: body weights were within the range of variation of this strain.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- [2-(perfluorohexyl)ethyl]trimethoxysilane has been tested in a guinea-pig maximisation (Buehler) study conducted according to OECD 406 and in compliance with GLP. None of the animals challenged for 6 hours to the test item or the negative control showed any evidence of sensitisation at either 24 or 48 hours after removing the patch.
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