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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
Endpoint summary
Administrative data
Description of key information
In the key in vivo skin irritation study, conducted according to EPA OPP 81-5 (Acute Dermal Irritation, similar to OECD Test Guideline 404) and in compliance with GLP (reliability score 1, SafePharm Laboratories Limited, 1995d), the study authors concluded that 3-(trimethoxysilyl)propyl acrylate (CAS No. 4369-14-6, EC No. 419-560-6) causes severe skin irritation to rabbit skin following 4-hour semi-occluded dermal application. However, the study reviewer considers that the observed effects indicate the test substance causes skin corrosion based on the dermal effects still evident at the last (day 7) observation timepoint. The corrosion interpretation is consistent with Annex VI of Regulation (EC) No. 1272/2008.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- 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
- 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)
- 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 - 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 - 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. - 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]]]
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the key in vivo skin irritation study, conducted according to EPA OPP 81-5 (Acute Dermal Irritation) and in compliance with GLP (reliability score 1, SafePharm Laboratories Limited, 1995d), 0.5 ml of undiluted 3-(trimethoxysilyl)propyl acrylate was applied onto the clipped dorsal area of 6 rabbits under semi-occlusive dressing for 4 hours. Following patch removal, any residual test item was removed by gentle swabbing with cotton wool soaked in 74% industrial methylated spirits and skin irritation reactions were assessed at 1, 24, 48 and 72 hours and up to day 7.
Well-defined erythema and slight to severe oedema were noted in animals at 1 and 24 hours after patch removal. Well-defined to severe erythema and very slight or severe oedema were observed at 48 hours. Very slight to severe erythema and very slight to severe 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 one 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 day 7 observation were crust formation or desquamation, with these reactions extending up to 6 cm beyond all sites at this timepoint.
The study authors concluded that 3-(trimethoxysilyl)propyl acrylate causes severe skin irritation to rabbit skin following 4-hour semi-occluded dermal application. However, the study reviewer concludes the test substance causes skin corrosion based on the dermal effects still evident at the last (day 7) observation timepoint.
Based on the current classification criteria, the reviewer concludes the data indicate classification as Skin Corrosion Category 1C. However, in the absence of further information, the harmonised classification of Skin Corrosion Category 1B is implemented for the registered substance and is consistent with the Annex VI of Regulation (EC) No. 1272/2008.
Justification for classification or non-classification
3-(Trimethoxysilyl)propyl acrylate is classified for skin corrosion Category 1B, H314: "Causes severe skin burns and eye damage" according to Annex VI of Regulation (EC) No. 1272/2008, with the eye Category 1 classification triggered by the harmonised skin classification.
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