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Diss Factsheets
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EC number: - | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data was taken from secondary sources
Data source
Reference
- Reference Type:
- other: Secondary source
- Title:
- SIDS Initial Assessment Report For SIAM 17 OECD SIDS SIAM,2003 OECD SIDS
- Author:
- OECD SIDS
- Year:
- 2 003
- Bibliographic source:
- OECD SIDS SIAM,2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1987
- Principles of method if other than guideline:
- Skin Sensitisation guideline OECD 406
- Principle of test: Skin senistisation test were carrierd out to determind the erythma and edema score, ny buhlers test
- Short description of test conditions: Erythma and Edema score were noted
- Parameters analysed / observed: - GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation 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.
Test material
- Reference substance name:
- 3-aminopropyltriethoxysilane
- EC Number:
- 213-048-4
- EC Name:
- 3-aminopropyltriethoxysilane
- Cas Number:
- 919-30-2
- Molecular formula:
- C9H23NO3Si
- IUPAC Name:
- 3-AMINOPROPYLTRIETHOXYSILANE
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Not specified
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no/not specified] No data available
- Microbiological status of animals, when known: No data available
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
- Indication of any skin lesions: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C):No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
- IN-LIFE DATES: From: To: No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction .5 % intracutaneous
Induction 50 % open epicutaneous
Challenge 50 % open epicutaneous - Day(s)/duration:
- Not specified
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- INDUCTION
intradermal: 0.5%
dermal: 50%
CHALLENGE
dermal: 50% - Day(s)/duration:
- not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- test: 20
negative controls: 10
positive controls: 20 test; 10 control - Details on study design:
- 1st: Induction .5 % intracutaneous
2nd: Induction 50 % open epicutaneous
3rd: Challenge 50 % open epicutaneous - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: 24h 48 h
- Group:
- negative control
- Dose level:
50% aqueous- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: 24h 48 h
- Group:
- test chemical
- Dose level:
50% aqueous- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Not specified
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
No adverse skin reactions were noted at the test material or vehicle control sites of the test or control animals at the 24 or 48 h observations.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- A generally well-conducted, well-reported, guinea-pig maximization test found that the hydrolysis products of 3-aminopropyltriethoxysilane (CAS 919-30-2)silane (50% aqueous) did not elicit a delayed contact hypersensitivity response in guinea pigs. Observed were appropriate negative and positive compliance controls concurrently in operation.
- Executive summary:
In accordance with the test guideline 406 Acute skin sensitization test, the RA chemical 3 aminopropyltriethoxysilane ( CAS number: 919-30-2)was studied using a guinea pig (Guinea pig maximization test).
In the induction group, the test sample was applied through intradermal and epicutaneous routes at a concentration range of Induction .5 % intracutaneous, Induction 50 % open epicutaneous, and Challenge 50 % open epicutaneous. using water as a vehicle.
After 24h and 48 hrs of observation in the test chemical group at 50% aqueous group skin sensations was not observed, similar for negative test group No adverse skin reactions were noted at the test material or vehicle control sites of the test or control animals at the 24 or 48 h observations.
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