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EC number: 419-560-6 | CAS number: 4369-14-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-6 (Skin Sensitisation)
- Version / remarks:
- 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- 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 guinea pig maximisation test method conducted in 1995
Test material
- Reference substance name:
- -
- EC Number:
- 419-560-6
- EC Name:
- -
- Cas Number:
- 4369-14-6
- Molecular formula:
- C9H18O5Si
- IUPAC Name:
- 3-(trimethoxysilyl)propyl prop-2-enoate
- Test material form:
- liquid
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: 32 females supplied by Charles River (UK) Ltd., Margate, Kent, UK. and 4 females by David Hall, Darley Oaks Farm, Newchurch, Burton-on-Trent, Staffs.
- Females nulliparous and non-pregnant: Not specified
- Microbiological status of animals, when known: Not specified
- Age at study initiation: 12 weeks old
- Weight at study initiation: 300-415 g
- Housing: Individually or in pairs
- Diet (e.g. ad libitum): Guinea Pig FD1 Diet, ad libitum
- Water (e.g. ad libitum): Mains tap water, ad libitum
- Acclimation period: At least 5 days
- Indication of any skin lesions: No skin lesions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 39-63
- Air changes (per hr): 15
- Photopersiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: See concentration / amount
- Concentration / amount:
- In test animals (shoulder region):
1) Freund's Complete Adjuvant plus distilled water in 1:1 ratio
2) A 1% w/v dilution of test material in arachis oiil
3) A 1% w/v dilution of test material in a 1:1 preparation of Freund's Complete Adjuvant plus arachis oil - Day(s)/duration:
- on study day 0 for 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- In test animals (same shoulder region), 100% undiluted test material
- Day(s)/duration:
- on study day 7 for 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- other: See concentration / amount
- Concentration / amount:
- In control animals (shoulder region):
1) Freund's Complete Adjuvant plus distilled water in 1:1 ratio
2) 100% arachis oil
3) 50% arachis oil in a 1:1 preparation of Freund's Complete Adjuvant plus distilled water - Day(s)/duration:
- on study day 0 for 48 hours
- Adequacy of induction:
- other: control animals with induction media as described
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: See concentration / amount
- Concentration / amount:
- In control animals (same shoulder region), nothing was applied to the filter paper
- Day(s)/duration:
- on study day 7 for 48 hours
- Adequacy of induction:
- other: control animals as described
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: See concentration / amount
- Concentration / amount:
- In test animals:
1) 100% test substance applied on the shorn right flank
2) 75% test substance in arachis oil applied to a separate site on the shorn right flank
3) 100% arachis oil applied on the shorn left flank - Day(s)/duration:
- on study day 21 for 24 hours
- Adequacy of challenge:
- other: Highest non-irritant test substance concentration (75-100%, two sites) plus a control (vehicle) site
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: See concentration / amount
- Concentration / amount:
- In control animals:
1) 100% test substance applied on the shorn right flank
2) 75% test substance in arachis oil applied to a separate site on the shorn right flank
3) 100% arachis oil applied on the shorn left flank - Day(s)/duration:
- on study day 21 for 24 hours
- Adequacy of challenge:
- other: Highest non-irritant test substance concentration (75-100%, two sites) plus a control (vehicle) site
- No. of animals per dose:
- Test animals: 20F total, treatment sites as described in the induction and challenge tables above
Control animals: 10F total, treatment sites as described in the induction and challenge tables above - Details on study design:
- RANGE FINDING TESTS: The concentrations used in the main study were selected based on the findings of a sighting test.
- Intradermal induction: Two animals were intradermally injected with 1% or 5% w/v test material in arachis oil. The highest concentration that did not cause local necrosis, ulceration or systemic toxicity was selected for the intradermal induction stage of the main study.
- Topical induction: The two animals subject to the intradermal induction, were also subject to topical induction 15 days later. At this time, the undiluted test material and preparations at 25%, 50% and 75% v/v concentrations in arachis oil were applied onto the skin for 48 hours under occlusive dressing. The highest concentration producing only mild to moderate dermal irritation were selected for the topical induction phase of the main study.
- Challenge phase: Two animals were subject to 48-hour occlusive topical challenge application of the undiluted test material and preparations at 25%, 50% and 75% v/v concentrations in arachis oil. The highest non-irritant concentration and one lower were selected for the challenge phase of the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal injection followed by topical induction one week later)
- Exposure period: Not applicable for intradermal injections; 48 hours for topical induction phase
- Test groups: 20 test animals were treated as described in the induction table above
- Control group: 10 control animals were treated as described in the induction table above
- Site: Shoulder region, as described in the induction table above
- Frequency of applications: Intradermal injections on day 1 followed by topical induction on day 7
- Duration: Not applicable for intradermal injections; 48 hours for topical induction phase
- Concentrations: As described in the induction table above
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: One day of challenge application, performed on study day 21
- Exposure period: 24 hours
- Test groups: 20 animals were treated as described in the challenge table above
- Control groups: 10 animals were treated as described in the challenge table above
- Site: Flanks as described in the challenge table above
- Evaluation (hr after challenge): at 24, 48 and 72 hours - Challenge controls:
- At challenge, the control animals were exposed to 100% test material in arachis oil, 75% test item in arachis oil, and 100% arachis oil. No erythema, oedema, or dermal reactions (except from patch removal) in the three control groups.
- Positive control substance(s):
- yes
- Remarks:
- a-hexylcinnamaldehyde, 2-mercaptobenzothiazole, ethyl-4-aminobenzoate, and 2,4-dinitrochlorobenzene; data collected November 1993 to November 1994
Results and discussion
- Positive control results:
- Based on positive control data from November 1993 to November 1994, the four positive controls yielded incidences of sensitisation as foillows:
* 7/10 for a-hexylcinnamaldehyde (tech 85%; undiluted and 75% in arachis oil)
* 8/10 for 2-mercaptobenzothiazole (purity not specified; 25% in 95% aqueous ethanol)
* 7/18 for ethyl-4-aminobenzoate (98%; 10% and 5% in 80% aqueous ethanol), and
* 9/9 for 2,4-dinitrochlorobenzene (purity not specified; 0.1% and 0.05% in arachis oil)
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Test animals
- Dose level:
- 100% test substance
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Test animals
- Dose level:
- 100% test substance
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Test animals
- Dose level:
- 75% test substance in arachis oil
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Test animals
- Dose level:
- 75% test substance in arachis oil
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Test animals (vehicle treatment)
- Dose level:
- 100% arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Test animals (vehicle treatment)
- Dose level:
- 100% arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Control animals
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Control animals
- Dose level:
- 100% test substance
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Control animals
- Dose level:
- 75% test substance in arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Control animals
- Dose level:
- 75% test substance in arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Control animals
- Dose level:
- 100% arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Control animals
- Dose level:
- 100% arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: not specified
- Group:
- other: Positive control data
- Dose level:
- a-hexylcinnamaldehyde (tech 85%), undiluted and 75% in arachis oil B.P
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- other: positive indication of skin sensitisation, positive control data from Nov 1993 to Nov 1994
- Key result
- Reading:
- other: not specified
- Group:
- other: Positive control data
- Dose level:
- 2-mercaptobenzothiazole, 25% in 95% aqueous ethanol
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: positive indication of skin sensitisation, positive control data collected Nov 1993 to Nov 1994
- Key result
- Reading:
- other: not specified
- Group:
- other: Positive control data
- Dose level:
- ethyl-4-aminobenzoate (98%), 10% and 5% in 80% aqueous ethanol
- No. with + reactions:
- 7
- Total no. in group:
- 18
- Remarks on result:
- other: positive indication of skin sensitisation, positive control data collected Nov 1993 to Nov 1994
- Key result
- Reading:
- other: not specified
- Group:
- other: Positive control data
- Dose level:
- 2,4-dinitrochlorobenzene, 0.1% and 0.05% in arachis oil B.P
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Remarks on result:
- other: positive indication of skin sensitisation, positive control data collected Nov 1993 to Nov 1994
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- This classification is consistent with Annex VI of Regulation (EC) No. 1272/2008.
- Conclusions:
- In the in vivo skin sensitisation study, conducted according to EPA OPP 81-6 (Skin Sensitisation; similar to OECD Test Guideline 406) and in compliance with GLP, 3-(trimethoxysilyl)propyl acrylate produced up to 70% sensitisation in guinea pigs treated with undiluted or 75% test substance in arachis oil.
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