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EC number: 219-698-5 | CAS number: 2499-95-8
- 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)
- Remarks:
- Freud's Complete Adjuvant Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Sensitizing potential of 14 mono (meth) acrylates in the guinea pig
- Author:
- H. B. Van Der Walle, G. Klecak, H. Geleick, T. Bensink
- Year:
- 1 982
- Bibliographic source:
- Contact Dermatitis Vol. 8:223-235
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- Albino female guinea pigs (350-450 g) of the Dunkin Hartley outbred strain (Olac Ltd. Bicester England). Guinea pigs were housed in pairs and fed a pellet diet supplemented with water containing vitamin C ad libitum.
Skin irritation was assessed by a single open application of 0.025 mL to a 2 cm2 area of the clipped flank of 8 animals. A mixture of 2 parts Methyl Ethyl Ketone and one part peanut oil by volume was used as a solvent. Skin reactions were read after 24 and 48 hours and reported as maximum non-irritating concentration (m.n.i.c).
Induction- On days 0, 2, 4, 7, and 9 intradermal injections with 0.1 mL of test substance emulsified in FCA were given in the shoulder area.
Challenge- Animals were challenged epicutaneously onto the shaven right flank at day 21 and shaven left flank on day 35. N-hexyl acrylate was solubilized inFCA and 0.025 mL was applied to a 2 cm2 area.
Concentrations: Induction- 0.5 M of n-hexyl acrylate in FCA; Challenge- maximum non-irritating concentration, 1M - GLP compliance:
- not specified
- Type of study:
- Freund's complete adjuvant test
- Justification for non-LLNA method:
- Study conducted prior to development of LLNA method.
Test material
- Reference substance name:
- Hexyl acrylate
- EC Number:
- 219-698-5
- EC Name:
- Hexyl acrylate
- Cas Number:
- 2499-95-8
- Molecular formula:
- C9H16O2
- IUPAC Name:
- hexyl prop-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Polysciene Inc.
- Expiration date of the lot/batch: not specified
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Institute for Biomedical Research Fullinsdorf Switzerland
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: not specified
- Age at study initiation: not specified
- Weight at study initiation: 350 - 450 g
- Housing: pair housed
- Diet (e.g. ad libitum): Pellet diet
- Water (e.g. ad libitum): water supplmented with vitamin C
- Acclimation period: not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- arachis oil
- Concentration / amount:
- Concentration: 0.5 M (8.6%); Amount: 0.1 mL n-hexyl acrylate in peanut oil
- Day(s)/duration:
- Day 0, 2, 4, 7 and 9
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- arachis oil
- Concentration / amount:
- Concentration 1.0 M/ Amount applied 0.025 mL
- Day(s)/duration:
- Day 21/ 24 hours duration
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- arachis oil
- Concentration / amount:
- Concentration 1.0 M/ Amount applied 0.025 mL
- Day(s)/duration:
- Day 35/ 24 hours duration
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Experimental: 8; Control: 4 - 6
- Details on study design:
- RANGE FINDING TESTS:
Skin irritation was assessed by a single open application of 0.025 mL to a 2 cm2 area of the clipped flank of 8 animals. A mixture of 2 parts Methyl Ethyl Ketone and one part peanut oil by volume was used as a solvent. Skin reactions were read after 24 and 48 hours and reported as maximum non-irritating concentration (m.n.i.c).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 5
- Exposure period: Day 0, 2, 4, 7 and 9
- Test groups: 0.1 mL intradermal injections of 0.5M of n-hexyl acrylate in FCA and equal volume of distilled water
- Control group: Same treatment as test group with acrylate omitted
- Site: 4X6 cm clipped area of shoulder
- Frequency of applications: single
- Duration: not applicable for injection
- Concentrations: 0.5 M
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: Day 21 and Day 35
- Test groups: Day 21: 0.025 mL of solubilized n-hexyl acrylate in FCA onto an uncovered area of 2 cm2; Day 35: 0.025 mL of solubilized n-hexyl acrylate in FCA onto an uncovered area of 2 cm2
- Control group: Same treatment as test group with acrylate omitted
- Site: Day 21: shaved right flank; Day 35: shaved left flank
- Concentrations: 1.0 M
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0 M
- No. with + reactions:
- 8
- Total no. in group:
- 8
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0 M
- No. with + reactions:
- 8
- Total no. in group:
- 8
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The Freud's complete adjuvant test to assess the skin sensitization potential of n-hexyl acrylate (>99% purity) was positive. This finding warrants the classification of n-hexyl acrylate as a skin sensitizer Ctaegory 1B under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
- Executive summary:
N-hexyl Acrylate (>99% purity) was examined for its potential to be a skin sensitizer using the Freud's complete adjuvant test described by Klecak and Geleick. Following a preliminary irritation test, 8 guinea pigs were treated by intradermal injection (0.5M; 8.6% (w/v) vehicle/ n-hexyl acrylate) to induce sensitization. Guinea Pigs were challenged by topical application (1.0 M; 17.2% w/v n-hexyl acrylate in peanut oil). Indications of sensitization were noted in all eight animals. This finding warrants the classification of n-hexyl acrylate as a skin sensitizer Category 1B under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
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