Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Skin Sensitization-
Sensitizing to guinea pig (OECD 406 Guinea Pig Maximization Test)
Sensitizing to guinea pig (OECD 406 Freuds Complete Adjuvant Test)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation, other
- Remarks:
- Human Repeat Insult Patch Test (HRIPT)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Remarks:
- TSCA 8E Notification
- Principles of method if other than guideline:
- The repeat patch testing was conducted in 7 human volunteers (mix of male and female). A solution of 6% 2-propenoic acid, hexyl ester in dimethyl phthalate was applied daily (duration not specified) over 10 sessions within the sensitization phase. The sensitization phase was followed by a challenge after which skin reactions were evaluated.
Intensity of skin reactions were graded on a three scale system as follows:
+1: redness, slight puffiness, scaliness, and occasional pinpoint sized papules or small group of such papules
+2: plus one response in addition to larger numbers of pinpoint or slightly larger vesicles with an increased degree of redness and puffiness and generally some slight peripheral extension of this redness
+3: plus two response in addition to marked redness, considerable puffiness and swelling, large vesicles both discrete and coalescent with oozing and crusting as the vesicle ruptures. - GLP compliance:
- no
- Remarks:
- study predates GLP
- Type of study:
- patch test
- Species:
- other: human
- Sex:
- male/female
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 6%
- No. with + reactions:
- 7
- Total no. in group:
- 7
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The skin sensitization potential of n-hexyl acrylate (6% in dimethyl phthalate) produced seven of seven positive responses in a human repeat patch irritation test. This finding supports the classification of n-hexyl acrylate as a skin sensitizer under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
- Executive summary:
N-hexyl acrylate (6% in dimethyl phthalate) was examined for its potential to be a skin sensitizer following repeat application in a human patch test; a positive response was noted in all seven participants. This finding supports the classification of n-hexyl acrylate as a skin sensitizer under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
- 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
- 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.
- 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 - 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 - 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
- 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
- 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
- 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).
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Freud's Complete Adjuvant Test
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- 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.
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Department of Dermatology in Nijmegen
- Expiration date of the lot/batch: not specified
- Purity: contains up to 16% hexanol - 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 - 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
- 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: 6 - 10; 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:
- Site: Day 21: shaved right flank; Day 35: shaved left flank
- Concentrations: 1M
- Evaluation (hr after challenge): 24 and 48 hours - Positive control substance(s):
- no
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0 M
- No. with + reactions:
- 5
- 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:
- 5
- Total no. in group:
- 8
- Remarks on result:
- positive indication of skin sensitisation
- 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 (containing up to 16% hexanol) 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 (containing up to 16% hexanol) 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, 10 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 five out of 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).
Referenceopen allclose all
One response at plus one: redness, some slight puffiness
Three responses at plus two: plus one reaction with larger numbers of pin point or slightly larger vesicles with an increased degree of puffiness and redness with generally slight peripheral extension of redness
Three responses at plus three: plus two manifestions in addition to marked redness, considerable puffiness, and swelling; large vesicles both discreet and coalescent with oozing and crusting as the vesicles rupture.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Justification for classification or non-classification
The skin sensitizating potential for n-hexyl acrylate produced positive skin reactions in several in-vivo assays. This finding warrants the classification of n-hexyl acrylate as a skin sensitizer Category 1B under the Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.