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EC number: 418-140-1 | CAS number: 5117-12-4 ACRYLOYLMORPHOLIN
- 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
Several studies are available:
HRC 1994: The study is performed to assess the skin sensitization potential of the substance using guinea-pig, according to EU Method B6 under GLP. The following dose levels were administered: Intradermal injection 5%, topical application 30%, and challenge application 25% and 12.5%. Ten test and five control animals were used. The substance produced evidence of skin sensitization in six of ten test animals.
HLS 2001: The study is performed to assess the skin sensitization potential of the substance using guinea-pig, according to OECD Guideline 406 under GLP. The test substance as supplied was administered in both induction and challenge stage. Twenty test and ten control animals were used. The substance did not produce evidence of skin sensitization in any of test animals.
Harlan 2011: The study is performed to assess the skin sensitisation potential of the substance in mouse, according to OECD Guideline 429 under GLP. Three groups, each of four animals, were treated with test item at 25%, 10% or 5%. A further group of four animals were treated with vehicle alone. The SI values are determined as 1.32, 2.48 and 1.38 for 5%, 10% and 25% groups, respectively. The substance is considered to be a non-sensitiser in this test.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 24 May to 14 June 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Lot number: A
Purity: >99% - Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-23 g
- Housing: individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 10, 5% v/v
- No. of animals per dose:
- 4 mice each group
- Details on study design:
- PRE-SCREEN TESTS:
- Irritation: did not produce excessive local irritation at 25, 50%
- Systemic toxicity: did not produce systemic toxicity at 25%, one animal died at 50%
MAIN STUDY
Test item administration:
Mice were treated daily application of 25 uL of test item to dorsal surface of each ear for three consecutive days.
3H-Methyl thymidine administration:
5 days following first topical application of test item, all mice injected with 250 uL of PBS containing 3H-Methyl thymidine.
Observations:
All animals were observed twice daily on days 1, 2, 3 and daily basis on days 4, 5, 6. Bodyweight of each mouse was recorded on day 1 and day 6.
Terminal procedures:
5 hours after administration of 3HTdR all mice were killed by carbon dioxide asphyxiation. The draining auricular lymph nodes from the four mice were excised and pooled for each experiment group. For each group 1 mL of PBS was added to the pooled lymph nodes.
A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through 200-mesh stainless steel gauze. 3HTdR incorporation was determined after 8 hours incubation.
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: The test item will be regarded as sensitiser if at least one concentration of test item results in threefold or greater increase in 3HTdR incorporation compared to control values. - Positive control substance(s):
- not specified
- Key result
- Parameter:
- SI
- Value:
- 1.32
- Test group / Remarks:
- 5% v/v
- Key result
- Parameter:
- SI
- Value:
- 2.48
- Test group / Remarks:
- 10% v/v
- Key result
- Parameter:
- SI
- Value:
- 1.38
- Test group / Remarks:
- 25% v/v
- Cellular proliferation data / Observations:
- There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test. Slight redness on the ears was noted in two animals treated with test item at concentration of 25% v/v.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is considered to be a non-sensitiser in this test.
- Executive summary:
The study is performed to assess the skin sensitisation potential of the substance in mouse, according to OECD Guideline 429 under GLP. Three groups, each of four animals, were treated with test item at 25%, 10% or 5%. A further group of four animals were treated with vehicle alone.
The SI values are determined as 1.32, 2.48 and 1.38 for 5%, 10% and 25% groups, respectively. The substance is considered to be a non-sensitiser in this test.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 11 January to 21 February 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- the study was performed before amendment of Annex VII and VIII
- Specific details on test material used for the study:
- Batch number: 60513F07
Purity: 99.81% - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, England
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6-7 weeks
- Weight at study initiation: 308-371 g
- Housing: housed in groups of 10 in suspended metal cages with mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 30-70%
- Air changes: 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial light in each 24 hours period - Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5% v/v
- Day(s)/duration:
- single injection
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 30% v/v
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 12.5, 25% v/v
- Day(s)/duration:
- 2 weeks after final induction
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals
- Details on study design:
- RANGE FINDING TESTS: injection induction 5% v/v, topical induction 30% v/v, challenge 25 and 12.5% v/v. The results showed 25% v/v is considered to be maximum concentration would not give rise to irritating/adverse effects.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: single injection, and 48 hours for topical induction
- Site: injection at dorsal skin on scapular region, topical induction at interscapular area
- Frequency of applications: one week after injection, topical induction performed
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after final induction
- Exposure period: 24 hours
- Site: left flank, 20*20 mm
- Concentrations: 12.5, 25% v/v
- Evaluation (hr after challenge): 24, 48 and 72 hours after removal of patches - Challenge controls:
- 5 animals, 12.5, 25% v/v in water
- Positive control substance(s):
- yes
- Remarks:
- formalin
- Positive control results:
- Formalin produced evidence of skin sensitization in all animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% v/v
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- localised dermal reaction, necrotic patch; no signs of ill health or toxicity
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% v/v
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- localised dermal reaction, necrotic patch, tickening, dryness and sloughing of epidermis; no signs of ill health or toxicity
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The substance produced evidence of skin sensitization in six of ten test animals.
- Executive summary:
The study is performed to assess the skin sensitization potential of the substance using guinea-pig, according to EU Method B6 under GLP.
The following dose levels were administered: Intradermal injection 5%, topical application 30%, and challenge application 25% and 12.5%.
Ten test and five control animals were used. The substance produced evidence of skin sensitization in six of ten test animals.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From 19 July to 27 August 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- the study was performed before amendment of Annex VII and VIII
- Specific details on test material used for the study:
- Batch number: 06104056
Purity: 99.68% - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: D. Hall, Newchurch, England
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 7 weeks
- Weight at study initiation: 312-442 g
- Housing: housed in groups of 5 in suspended metal cages with mesh floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hours artificial light in each 24 hours period - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100% as supplied
- Day(s)/duration:
- 15 days
- 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:
- 100% as supplied
- Day(s)/duration:
- 2 weeks after final induction
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals
- Details on study design:
- RANGE FINDING TESTS: 25, 50, 75, 100% v/v to 4 animals, no sign of irritating effects. Test material administered topically as supplied in main study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours each exposure
- Site: left shoulder region, 2*2 cm
- Frequency of applications: on days 1, 8 and 15
- Duration: 15 days
- Concentrations: 100% as supplied
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after final induction
- Exposure period: 6 hours
- Site: right flank, 2*2 cm
- Concentrations: 100% as supplied
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- 10 animals, 100% as supplied
- Positive control substance(s):
- yes
- Remarks:
- hexyl cinnamic aldehyde
- Positive control results:
- HCA produced evidence of skin sensitization in all of 10 animals.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no deaths, no signs of ill health or toxicity, no dermal reactions
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% as supplied
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no deaths, no signs of ill health or toxicity, no dermal reactions
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance did not produce evidence of skin sensitization in any of test animals.
- Executive summary:
The study is performed to assess the skin sensitization potential of the substance using guinea-pig, according to OECD Guideline 406 under GLP. The test substance as supplied was administered in both induction and challenge stage. Twenty test and ten control animals were used. The substance did not produce evidence of skin sensitization in any of test animals.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
One guinea-pig study give positive result, another guinea-pig study give negative result; LLNA study give negative result.
Given the substance shows skin sensitizing potential in a reliable study, according to Regulation (EC) No 1272/2008, table 3.4.2, this substance should be classified as Category 1 for this endpoint.
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