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EC number: 220-237-5 | CAS number: 2680-03-7
- 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)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Near-guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- N,N-dimethylacrylamide
- EC Number:
- 220-237-5
- EC Name:
- N,N-dimethylacrylamide
- Cas Number:
- 2680-03-7
- Molecular formula:
- C5H9NO
- IUPAC Name:
- N,N-dimethylacrylamide
- Details on test material:
- - Name of test material (as cited in study report): NNDMA (N,N-dimethyl acrylamide)
- Physical state: clear liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Labs, Chelmsford, MA
- Housing: group housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cages and was changed at least three times per week.
- Diet: Purina Guinea Pig Chow #5025, ad libitum
- Water: filtered tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- First induction: intadermal injection (0.1 ml):
50% v/v Complete Freund's Adjuvant mixture in distilled water
test substance as a 5% w/w mixture in distilled water
5% w/w mixture of test substance in Complete Freund's Adjuvant (50% v/v in distilled water)
Second induction: topical application:
25% w/w
Challenge:
25% w/w
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- First induction: intadermal injection (0.1 ml):
50% v/v Complete Freund's Adjuvant mixture in distilled water
test substance as a 5% w/w mixture in distilled water
5% w/w mixture of test substance in Complete Freund's Adjuvant (50% v/v in distilled water)
Second induction: topical application:
25% w/w
Challenge:
25% w/w
- No. of animals per dose:
- 10 (test group)
5 (vehicle control) - Details on study design:
- RANGE FINDING TESTS:
Based on these findings of preliminary irritation screens, the concentration selected for the intradermal induction was a 5% w/w solution in distilled water, and that selected for the topical induction which produced faint irritation was a 25% w/w mixture in distilled water. The HNIC (the highest concentiation that produced responses in four guinea pigs no more severe than two scores of 0.5 and two scores of zero) selected for the challenge phase was a 25% w/w mixture in distilled water.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 10
- Control group: 5
- Site: suprascapular area
- Frequency of applications: once weekly
- Concentrations: 5 (intradermal injection) and 25% w/w (topical application, 48 hours)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: 10
- Control group: 5
- Site: naive site on each right side of test and sham control animal
- Concentrations: 25% w/w
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Six of the ten positive control animals exhibited signs of a sensitisation response (faint to moderate erythema [1-2]) 24 and 48 hours after challenge patch removal. Very faint erythema (0.5) was noted for three, other sites at the 24 and 48 hour interval.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 5 of 10 animals showed very faint erythema (grade: 0.5)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 5 of 10 animals showed very faint erythema (grade: 0.5).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 2 of 10 animals showed very faint erythema (grade: 0.5)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 2 of 10 animals showed very faint erythema (grade: 0.5).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- 1 of 5 animals showed very faint erythema (grade: 0.5)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: 1 of 5 animals showed very faint erythema (grade: 0.5).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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