Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 422-350-7 | CAS number: 5575-48-4
- 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
Endpoint summary
Administrative data
Description of key information
The in vivo skin sensitisation of Decyltrimethoxysilane was evaluated during a GLP-compliant study performed according to the method described by Buehler. This method is described in the OECD Testing Guideline 406.
Six male and six female Hartley albino guinea pigs received three topical, occluded applications of the test substance at 50% in corn oil during the induction period of three weeks. An additional group of five male and five female Hartley albino guinea pigs served as a control group.
Two weeks following the last induction application, the animals in the test group received a topical application of the test article, at the determined highest non-irritating concentration of 25% in corn oil, to a dorsal, virgin site. At the same time, the control group animals received an identical dosage of the test article. All challenges dosages were made without patches.
Observations of irritation and other effects were recorded 7 and 24 hours after each induction application and 7, 24 and 48 hours following the challenge applications.
None of the treated animals showed any sign of irritancy at 7, 24 and 48 hours following the challenge.
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:
- key study
- Study period:
- From 14 October 2004 to 19 November 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Reduced number of animals compared to number recommended in the Guideline.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Existing study performed in 2004 is used for the purpose of the REACH Registration of the substance.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals (Chelmsford, Massachusetts)
- Weight at study initiation: 326 to 446 g
- Housing: stainless steel cages
- Diet: Certified Guinea Pig Diet #5026 ad libitum
- Water: water (source not specified) ad libitum
- Acclimation period: eight days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65 to 75°F (equivalent to 18.33 to 23.89°C)
- Humidity (%): Monitored (variations not specified)
- Photoperiod (hrs dark / hrs light): 12h/12h - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.4 mL test substance at 50% in corn oil
- Day(s)/duration:
- Applications of six hours were made once per week for three consecutive weeks.
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 0.4 mL test substance at 25% in corn oil
- Day(s)/duration:
- 6h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Six animals per sex
- Details on study design:
- RANGE FINDING TESTS: Mildly irritating and highest non-irritating concentrations were determined before the induction phase.
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 6h
- Test groups: One treated group
- Control group: Five animals per sex
- Site: n°1
- Frequency of applications: 3
- Duration: 3 weeks
- Concentrations: 50% in corn oil
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge:
- Exposure period: 6h
- Test groups: One treated group
- Control group: Five animals per sex
- Site: n°3
- Concentrations: 25% in corn oil
- Evaluation: 7, 24, and 48 hr after challenge
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 7
- Group:
- test chemical
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 12
- Reading:
- 1st reading
- Hours after challenge:
- 4
- Group:
- negative control
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin sensitisation of Decyltrimethoxysilane was evaluated using the Buelher’s Test. None of the treated animals showed any sign of irritancy at 7, 24 and 48 hours following the challenge. The substance does not meet the criteria for classification as a skin sensitiser in accordance with Regulation (EC) No.1272/2008.
- Executive summary:
The in vivo skin sensitisation of Decyltrimethoxysilane was evaluated during a GLP-compliant study performed according to the method described by Buehler. This method is described in the OECD Testing Guideline 406.
Six male and six female Hartley albino guinea pigs received three topical, occluded applications of the test substance at 50% in corn oil during the induction period of three weeks. An additional group of five male and five female Hartley albino guinea pigs served as a control group.
Two weeks following the last induction application, the animals in the test group received a topical application of the test article, at the determined highest non-irritating concentration of 25% in corn oil, to a dorsal, virgin site. At the same time, the control group animals received an identical dosage of the test article. All challenges dosages were made without patches.
Observations of irritation and other effects were recorded 7 and 24 hours after each induction application and 7, 24 and 48 hours following the challenge applications.
None of the treated animals showed any sign of irritancy at 7, 24 and 48 hours following the challenge.
The substance does not meet the criteria for classification as a skin sensitiser in accordance with Regulation (EC) No.1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
The skin sensitisation of Decyltrimethoxysilane was evaluated using the Buelher’s Test. None of the treated animals showed any sign of irritancy at 7, 24 and 48 hours following the challenge. The substance does not meet the criteria for classification as a skin sensitiser in accordance with 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.