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EC number: 701-410-9 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01 September 2016 to 16 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- At the time of contracting this study the LLNA study was not performed because the test method was not considered to be suitable for substances that contain silicon.
Test material
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, protected from moisture
- Stability under test conditions: undergoes hydrolysis in water at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: The test material was dissolved in acetone.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: For the challenge 0.62 g of the test item was dissolved in acetone to give a final volume of 20 mL and to achieve a 3.1% concentration. The solution was prepared 55 minutes before application.
- Preliminary purification step (if any): not specified
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material): liquid
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:HA
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Microbiological status of animals, when known:
- Age at study initiation: approximately 5-6 weeks old
- Weight at study initiation: 302-389 g
- Housing: The animals were kept in groups of 5 animals in Terluran - cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): autoclaved hay and Altromin 3122 maintenance diet for guinea pigs, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
- Indication of any skin lesions: none specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- 6 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- 3.1%
- Day(s)/duration:
- 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary test: 8
Test group: 20
Negative control group: 10 - Details on study design:
- RANGE FINDING TESTS: The adequate concentrations for the inductions and the challenge were determined by a preliminary test with different concentrations. Either the undiluted test sample or each of two concentrations of the test sample diluted with the vehicle were applied topically to the flanks of the animals for 6 hours using occlusive dressings. Two animals were treated with each concentration. As the test item was irritating, the highest concentration to cause mild irritation for each induction exposure and the highest non-irritating concentration for the challenge exposure were determined.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three induction exposures
- Exposure period: 6 hours
- Test groups: A Hill Top Chamber was loaded with 0.5 ml of 100% test substance. Then it was applied to the test area of approximately 2.5 x 2.5 cm and was held in contact with the help of hypoallergenic surgical tape and hypoallergenic elastic bandage for 6 hours.
- Control group: Hill Top Chamber was applied to the negative control group
- Site: the left flank
- Frequency of applications: once a week for three weeks
- Duration: 6 hours
- Concentrations: 100 % test item
B. CHALLENGE EXPOSURE
- No. of exposures: One exposure
- Day(s) of challenge: 14 days after the last induction.
- Exposure period: 6 hours
- Test groups: 0.5 mL of the prepared test substance was loaded on a Hill Top Chamber and applied to an area of approximately 2.5 x 2.5 cm on the right flank and was held in contact with the help of an occlusive dressings.
- Control group: A Hill Top Chamber was loaded with 0.5 mL of the vehicle and was applied to the left flank at an untreated site and was held in contact with the help of an occlusive dressing.
- Site: left flank
- Concentrations: 3.1% in acetone
- Evaluation (hr after challenge): 24 and 48 hours
- Challenge controls:
- A Hill Top Chamber loaded with 0.5 mL of the vehicle was applied to an area of approx. 2.5 x 2.5 cm on the left flank at an untreated site (intraspecific control) and was held in contact with the help of an occlusive dressing for 6 hours.
- Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole, purity > 98%
Results and discussion
- Positive control results:
- The sensitisation rate after application of the positive control substance mercaptobenzothiazole (25% in vaseline) was 80%, confirming the reliability of the test system.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3.1% test substance in acetone
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- 2 animals with erythema grade 2; 11 animals with erythema grade 1
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% acetone (vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 3.1% test substance in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3.1% test substance in acetone
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Clinical observations:
- 2 animals with erythema grade 2;11 animals with erythema grade 1.
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% acetone (vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 3.1 % test substance in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
- Conclusions:
- In the skin sensitisation study, conducted according to an appropriate OECD Test Guideline 406 and in compliance in GLP, the test substance, trimethoxy(methyl)silane and its reaction products with 3-aminopropyltriethoxysilane and [3-(2,3-epoxypropoxy)propyl]trimethoxysilane, was reported to be sensitising to skin.
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.
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