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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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 81-5 (Acute Dermal Irritation)
- Version / remarks:
- 1984
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 weeks old
- Weight at study initiation: 2.25-2.82 kg
- Housing: Individually
- Diet (e.g. ad libitum): STANRAB SQC Rabbit Diet, ad libitum
- Water (e.g. ad libitum): Mains drinking water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 50-69
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- Up to 7 days
- Number of animals:
- 3M, 3F
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal/flank area
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: Surgical adhesive tape wrapped in an elasticated corset
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test item was removed by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
At 1 hour following the removal of the patches and approximately at 24, 48 and 72 hours after patch removal, the test site was examined for primary irritation.
SCORING SYSTEM:
- Method of calculation: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks:
- Noting, at this timepoint, crust formation and desquamation were noted at all treated skin sites. These reactions extended up to 6 cm at all treatment sites.
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Well-defined erythema (all animals) and slight (1 female) to severe oedema (3 animals at 1 hour, 5 animals at 24 hours) were noted in animals at 1 and 24 hours after patch removal. Well-defined (5 aninimals) to severe (1 female) erthema and very slight (one female) or severe (other 5 animals) edema were observed at 48 hours. Very slight (1 female) to severe (1 female) erythema and very slight (1 female) to severe ( 1 male and 1 female) oedema were seen at the 72-hour observation. The erythema extended up to 4 cm beyond all treatment sites at 1 hour after patch removal. The erythema extended up to 6 cm beyond for 5 treatment sites at the 24-hour observation, and 4 treatment sites at the 48-hour and 72-hour observations.
Haemorrhage of the dermal capillaries was noted at 1 treated skin site at 1 hour after patch removal and at the 24, 48 and 72-hour observations. Blanching of the skin around the edge of treatment site was noted at one treated skin site at the 24 and 48-hour observations. Light brown discolouration of the epidermis was noted at two treated skin sites at the 24, 48 and 72-hour observations. Skin reactions noted in all treated skin sites at the 7-day observation were crust formation or desquamation, with these reactions extending up to 6 cm beyond all treatment sites at this timepoint.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Remarks:
- Annex VI of Regulation (EC) No. 1272/2008 considers the classification to be Category 1B (corrosive), with this classification implemented for the registered substance.
- Conclusions:
- In the in vivo skin irritation study, conducted according to EPA OPP 81-5 (Acute Dermal Irritation) and in compliance with GLP, the study authors stated that 3-(trimethoxysilyl)propyl acrylate causes severe skin irritation to rabbit skin following 4-hour semi-occluded dermal application. However, the study reviewer concludes that the test substance causes skin corrosion based on the dermal effects still evident at the day 7 observation timepoint. Annex VI of (EC) No. 1272/2008 considers 3-(trimethoxysilyl)propyl acrylate to be corrosive/]h]]]
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