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EC number: 240-816-6 | CAS number: 16753-62-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to current OECD guideline and in compliance with GLP and considered reliability 1. Read-across is considered scientifically valid and reliability 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Trimethoxyvinylsilane
- EC Number:
- 220-449-8
- EC Name:
- Trimethoxyvinylsilane
- Cas Number:
- 2768-02-7
- IUPAC Name:
- trimethoxy(vinyl)silane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: mineral oil
- Concentration / amount:
- This study consisted of three phases. The Primary Irritation Phase consisted of an intradermal and a topical range-finding study. The intradermal range-finding study evaluated the irritation potential of A-171 in mineral oil and in a 1:1 Freund's Complete Adjuvant (FCA) and sterile saline mixture. The topical range-finding study was used to evaluate the irritation threshold concentration of A-171 following a single topical application. The definitive study consisted of the Induction Phase and the Challenge Phase.
Primary Irritation Phase: The Primary Irritation Phase utilized 28 guinea pigs. In the intradermal range finding study, two male and two female Hartley albino guinea pigs each received six 0.1 mL intradermal injections on the dorsal surface along the spine. The animals received injections of A-171 at 1%, 3%, or 5% in mineral oil or 1:1 FCA:sterile saline. In the topical range-finding study, 12 male and 12 female Hartley albino guinea pigs were each
exposed at 0.3 mL/site to five concentrations of A-171 in acetone (2.5%, to 50%), to nine concentrations of A-171 in mineral oil (0.5% tor 75%), or to undiluted A 171 or 100% mineral oil. There were three sites per guinea pig and four sites per concentration. The treatment was applied beneath a Hill Top Chamber® and held in place for six hours. The chambers were occluded with plastic wrap and overwrapped with Elastoplast tape. The treated sites were examined approximately 24 and 48 hours after the end of exposure. Based on the results, the concentrations chosen for intradermal induction dosing were 3% in 1:1 FCA:saline and 5% in mineral oil, and the concentration chosen for topical induction dosing was 5% in mineral oil. The highest non-irritating concentration, 5% in mineral oil, was chosen for challenge dosing.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- This study consisted of three phases. The Primary Irritation Phase consisted of an intradermal and a topical range-finding study. The intradermal range-finding study evaluated the irritation potential of A-171 in mineral oil and in a 1:1 Freund's Complete Adjuvant (FCA) and sterile saline mixture. The topical range-finding study was used to evaluate the irritation threshold concentration of A-171 following a single topical application. The definitive study consisted of the Induction Phase and the Challenge Phase.
Primary Irritation Phase: The Primary Irritation Phase utilized 28 guinea pigs. In the intradermal range finding study, two male and two female Hartley albino guinea pigs each received six 0.1 mL intradermal injections on the dorsal surface along the spine. The animals received injections of A-171 at 1%, 3%, or 5% in mineral oil or 1:1 FCA:sterile saline. In the topical range-finding study, 12 male and 12 female Hartley albino guinea pigs were each
exposed at 0.3 mL/site to five concentrations of A-171 in acetone (2.5%, to 50%), to nine concentrations of A-171 in mineral oil (0.5% tor 75%), or to undiluted A 171 or 100% mineral oil. There were three sites per guinea pig and four sites per concentration. The treatment was applied beneath a Hill Top Chamber® and held in place for six hours. The chambers were occluded with plastic wrap and overwrapped with Elastoplast tape. The treated sites were examined approximately 24 and 48 hours after the end of exposure. Based on the results, the concentrations chosen for intradermal induction dosing were 3% in 1:1 FCA:saline and 5% in mineral oil, and the concentration chosen for topical induction dosing was 5% in mineral oil. The highest non-irritating concentration, 5% in mineral oil, was chosen for challenge dosing.
- No. of animals per dose:
- Definitive study:
10/sex/dose with test material
5/sex/dose with Positive Control
5/sex/dose with Negative Control - Details on study design:
- On study day 0, a group of 10 male and 10 female Hartley albino guinea pigs was dosed intradermally (0.1 mL/site) with duplicate injections of a 1:1 mixture of FCA and sterile saline, a 5% w/v mixture of A-171 in mineral oil, and a 3% w/v mixture of A-171 in 1:1 FCA:saline. On study day 6, the application site of all animals was pretreated with 0.5 mL of 10% sodium lauryl sulfate (SLS). On study day 7, the test group was topically induced with 5%
A-171 in mineral oil (approximately 0.4 to 0.5 mL) using the procedure described above. The duration of exposure was forty-eight hours. Two weeks after the topical induction exposure, the animals were challenge dosed for detection of sensitization by topical application of 5% A-171 at 0.3 mL/site to previously unexposed areas of skin. The guinea pigs were observed twice daily for mortality for the duration of all phases of the study. All sites were depilated and graded at 24-hours and 48-hours using the 0-to-3 grading scale. The initial and final body weights of the animals were recorded. Grades of 1 or greater in the test group would indicate sensitization, provided grades of less than 1 are seen in the vehicle control animals. Body weights and clinical observations were recorded on the day before initiation of dosing and at termination. - Challenge controls:
- A positive control group of 5 male and 5 female guinea pigs was induced and challenged with -Hexylcinnamaldehyde (HCA; a known sensitizer). A naïve control group of 5 male and 5 female guinea pigs was dosed only at challenge with 5% A-171 in mineral oil at 0.3 mL/site and served as an irritation control.
- Positive control substance(s):
- yes
- Remarks:
- Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- 9/10 and 4/10 animals 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:
- 5% A-171 in mineral oil
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- 5 slight (grade 1) reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% A-171 in mineral oil. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: 5 slight (grade 1) reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% A-171 in mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% A-171 in mineral oil. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5% A-171 in mineral oil
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- 4 slight (grade 1) reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% A-171 in mineral oil. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 4 slight (grade 1) reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5% A-171 in mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% A-171 in mineral oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1% HCA in acetone
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- One moderate (grade 2) and 8 (grade 1) slight reactions
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1% HCA in acetone. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: One moderate (grade 2) and 8 (grade 1) slight reactions.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1% HCA in acetone
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- 4 slight (grade 1) responses
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 1% HCA in acetone. No with. + reactions: 4.0. Total no. in groups: 10.0. Clinical observations: 4 slight (grade 1) responses.
Any other information on results incl. tables
One Negative Control Group-I male died on study day 9. This death was considered a spontaneous occurrence and was replaced with a Negative
Control Group-II male. There were
no clinical findings or remarkable body weight changes noted
during the study.
The Sensitization Incidence Index for the test group was
calculated to be 0% (0/20) following challenge. The
Irritation Severity Index was 0.3 and 0.0 at the 24- and
48-hour evaluation, respectively, for the Test Group. The
Irritation Severity Index for the Negative Control Group was
0.4 and 0.0 at the 24- and 48-hour evaluations,
respectively. The Sensitization Incidence Index was
calculated to be 90% (9/10) for the Positive Control Group
following challenge dosing with 1.0% HCA in acetone. The
Irritation Severity Indices were 1.0 and 0.4 at 24 and 48
hours, respectively, for the Positive Control Group.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, A-171 did not elicit a delayed contact hypersensitivity response in guinea pigs.
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