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EC number: 202-223-0 | CAS number: 93-15-2
- 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 chemico
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Oct 2017-28 Feb 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- direct peptide reactivity assay (DPRA)
- Justification for non-LLNA method:
- The correlation of protein rectivity with skin sensitisation potential is well established. Haptenation i.e. covalent binding of low molecluar weight substances (Haptens) to proteins present in skin is considered a prominent mechanism through which chemicals or their metabolites become antigenic. Therefore, information inferred from the DRPA assay is relevant for assessment for skin sensitisation potential of substances.
Test material
- Reference substance name:
- 4-allylveratrole
- EC Number:
- 202-223-0
- EC Name:
- 4-allylveratrole
- Cas Number:
- 93-15-2
- Molecular formula:
- C11H14O2
- IUPAC Name:
- 1,2-dimethoxy-4-(prop-2-en-1-yl)benzene
- Test material form:
- liquid
Constituent 1
In chemico test system
- Details on the study design:
- Solutions of test item and positive control prepared at 100 mM concentration were used in the sample preparation for analysis. Test solution, positive control and reference control was added to cysteine and lysine peptides and incubated in dark at 25°C for 24±2 hours. The test samples were then loaded in HPLC auto sampler to measure the peptide depletion. The test samples were then analysed by reversed-phase HPLC coupled with UV detector for detection of peptides at 220nm. The HPLC column Zorbax SBC18 (2.1mm X100mm X 3.5 micron) was equilibrated at 30°C with 50% phase A (0.1% (v/v) trifluoroacetic acid in water) and 50% phase B (0.085% (v/v) trifluoroacetic acid in acetonitrile). Analysis was carried out at a flow rate of 0.35 mL/min, with sample injection volume range of 10 μL. A linear gradient from 10% to 25% Acetonitrile over 10 minutes, was used for separation, followed by a rapid increase to 90% acetonitrile to remove other materials. Cysteine and lysine peptide Percent Depletion Values were then calculated from peptide peak areas obtained from the HPLC analysis.
Results and discussion
- Positive control results:
- Cinnamaldehyde showed 71.03% mean cysteine depletion and 35.59% mean lysine peptide depletion.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Parameter:
- other: % of cysteine peptide depletion
- Value:
- 4.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Parameter:
- other: % of lysine peptide depletion
- Value:
- 1.09
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Reactivity class classification of test item and positive control as per cysteine 1:10 lysine 1:50 prediction model.
Sample ID | Name of the chemical | Mean % of cysteine peptide depletion | Mean % of lysine peptide depletion | Mean peptide % peptide depletion | Reactivity class | DPRA prediction |
Y02 -01 | 4 -allylveratrole, Methyl Eugenol | 4,90 | 1,09 | 3,00 | No or minimal acticity | Negative |
CA | Cinnamic aldehyde | 71,03 | 35,59 | 53,31 | High reactivity | Positive |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean percent depletion was 4.90% for cysteine peptide and 1.09% for lysine peptide. The mean of cysteine and lysine peptide depletion was 3.00% which shows that the test item has no or minimal activity according to cysteine 1:10/lysine 1:50 prediction model. Hence it was concluded that the test item 4-allyveratrole, Methyl Eugenol is negative in skin sensitisation test by DPRA.
- Executive summary:
Skin sensitisation by in chemico test method, Direct Peptide Reactivity Assay (DPRA) was carried out using the nucleophile containing synthetic cysteine and lysine peptides to evaluate skin sensitisation potential of the test item 4 -allylveratrole (Methyl Eugenol). The mean percent depletion was 4.90% for cysteine peptide and 1.09% for lysine peptide. The mean of cysteine and lysine peptide depletion was 3.00% which shows that the test item has no or minimal activity according to cysteine 1:10/lysine 1:50 prediction model. Under the same conditions positive control cinnamaldehyde showed 71.03% and 35.59% mean cysteine and lysine peptide depletion confirming the sensitivity of the assay. Under the test conditions, test item, 4 -allylveratrole, Methyl Eugenol was concluded as negative in the skin sensitisation assay by direct peptide reactivity assay (DPRA).
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