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EC number: 606-936-1 | CAS number: 2210-24-4
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The REACH regulation requires, according to Annex VII point 8.3 column 2, the performance of an LLNA study as the first choice method for in vivo sensitisation testing, at the same time suggesting that only in exceptional circumstances another test should be used (e.g. Magnusson and Kligman study (OECD 406)), for animal welfare reasons.
However, despite that the LLNA was developed as an alternative approach to the long established GPMT assay, its ability to discriminate between allergens and irritants is known to be limited. According to OECD 429 (24th April 2002): “Despite the advantages of the LLNA over traditional guinea pig tests, it should be recognised that there are certain limitations that may necessitate the use of traditional guinea pigs tests (e.g., false negative findings in the LLNA with certain metals, false positive findings with certain skin irritants).
The substance N-phenylacrylamide (CAS: 2210-24-4) is a solid organic substance (melting point 105°C) and is classified as irritating to skin (according to regulation (EC) No.: 1272/2008: Category 2, H315: Causes skin irritation). Based on the fact that certain skin irritants gave false positive findings in the LLNA (standard procedure), it was decided to conduct the more robust Magnusson and Kligman study instead of the Local Lymph Node Assay, to avoid any interference of potential skin irritating effects on the overall assay outcome.
In conclusion, N-phenylacrylamide was found to be not sensitising to guinea pigs in a test model according to the MAGNUSSON and KLIGMAN method and must not be classified according to regulation (EC) No.: 1272/2008.
Test material
- Reference substance name:
- N-phenylprop-2-enamide
- EC Number:
- 606-936-1
- Cas Number:
- 2210-24-4
- Molecular formula:
- C9 H9 N O
- IUPAC Name:
- N-phenylprop-2-enamide
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: first by intracutaneous application (shoulder region) and 7 days later by topical administration (shoulder region)
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 10% suspension for the 1st (intracutaneous) induction stage, 75% suspensions for the 2nd (topical) induction stage and for the challenge
Challenge
- Route:
- other: topical (flank region)
- Vehicle:
- other: sesame oil
- Concentration / amount:
- 10% suspension for the 1st (intracutaneous) induction stage, 75% suspensions for the 2nd (topical) induction stage and for the challenge
- No. of animals per dose:
- 15 (5 for vehicle control and 5 for test item)
20 (for positive control, obtained from the historical background of this test laboratory) - Positive control substance(s):
- yes
- Remarks:
- alfa-hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- Animals of the same strain treated with alfa-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2) or a discrete or patchy erythema (grade 1).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: both flanks
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- highest dose level
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- other: both flanks
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- highest dose level
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- highest dose level
- Reading:
- other: both flanks
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- no test substance
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other: both flanks
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- no test substance
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- other: left flank
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- alfa-hexyl cinnamic aldehyde
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Reading:
- other: right flank
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- alfa-hexyl cinnamic aldehyde
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- other: left flank
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- alfa-hexyl cinnamic aldehyde
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Reading:
- other: right flank
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- alfa-hexyl cinnamic aldehyde
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
Body weight gain was within the range of the vehicle control during the experiment.
No necropsy was performed. No animal was found dead or was sacrificed in extremis during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- Skin sensitisation potential of CH03859 was determined using the OECD 406 protocol (guinea pig maximisation test). No skin sensitisation was observed for any of the guinea pigs in the study. Therefore, CH03859 does not need to be classified for skin sensitisation.
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