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Diss Factsheets
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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 27 October 2017-23 November 2017
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes
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 vitro test system
- Test system:
- human skin model
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
EpiSkin Small Model kit provided by SkinEthic
- Model used: EpiDerm™ (EPI-200-SIT)
- Tissue batch number(s): 17-EKIN-044
- Delivery date: 31 October , 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: incubator 37±1°C
- Temperature of post-treatment incubation (if applicable): incubator 37±1°C, 5±1% CO2 - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 10 ul
- Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 h
- Number of replicates:
- Three
Test system
- Details on study design:
- The test item was tested for possible skin irritation potentiial using RHE model, EpiSkin through topical application for 15 minutes. After 42 hour post-incubation perod, irritation potential of the test item was evaluated by assessing cytotoxic (irritancy) effect. Cytotoxicity is expressed as a reduction of mitochodrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 122.59
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Skin irritation potential of 4 -allylveratrole after 15 min exposure in reconstructed human epidermis (RHe)
Sample | OD Mean | SD of OD | Viability mean % | In vivo prediction |
Negative control | 0,646587 | 0,006166 | 100 | NI |
Positive control | 0,03837 | 0,001103 | 5,93 | I |
Test item | 0,79262 | 0,001477 | 122,59 | NI |
OD= optical density
S=standard deviation
NI=non-irritant
I=irritant
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item, Methyl Eugenol/4-allylveratrole, is non-irritant in the in vitro skin irritation test using reconstructed human epidermis.
- Executive summary:
The test item 4 -allylveratrole/Methyl Eugenol was tested for its possible skin irritation potential using a three dimestional Reconstructed Human Epidermis model, EpiSkin. The magnitude of viability was quantified by using MTT test. Validity of the test method was ascertained by positive control 5% SDS. Three tissue replicates were used for each treatment (exposure time 15 minutes), including negative and positive control.
The tissue viability met the acceptance criterion. Mean OD570 of negative control was 0,646587. The viability of culture treated by positive control 5% SDS was 6.9%. The positive control met the acceptance criterion: mean tissue viability less than 20%. Determined viability of culture treated by 4 -allylveratrole/Methyl Eugenol (122,59%) fulfilled the criteria for non-irritancy. Therefore, the is considered to be non-irritant to the skin.
Criteria for interpretation
Classification UN GHS
Mean tissue viability is≤50%
Category 2 or Category 1
Mean tissue viability > 50%
Non-Irritant
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