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EC number: 203-109-3 | CAS number: 103-41-3
- 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:
- 09.06 - 20.06.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2015
- Deviations:
- yes
- Remarks:
- However, the deviations did not influence the outcome or the validity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2009
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium fuer Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden
Test material
- Reference substance name:
- Benzyl cinnamate
- EC Number:
- 203-109-3
- EC Name:
- Benzyl cinnamate
- Cas Number:
- 103-41-3
- Molecular formula:
- C16H14O2
- IUPAC Name:
- benzyl 3-phenylacrylate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not applicable
- Source strain:
- other: not applicable
- Justification for test system used:
- Dermal irritation is usually determined in vivo in the Draize rabbit skin irritation test as described in OECD guideline 404. Because systemic reactions play a minor role in modulating local skin toxicity potential of chemicals, skin irritation potential may be predicted by in vitro systems, provided they are sufficiently complex to mimic human skin barrier and cell reactivity. In an international prevalidation study performed by ECVAM, the in vitro skin irritation test using the human skin model EpiDermTM and EpiSkinTM and measurement of cell viability by dehydrogenase conversion of MTT into a blue formazan salt have turned out as a sufficiently promising predictor for skin irritancy potential.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDermTM tissues
- Tissue batch number(s): 23341
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 ± 1.5°C, 5 ± 0.5% CO2
- Temperature of post-treatment incubation (if applicable): 37 ± 1.5°C, 5 ± 0.5% CO2
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: at least 15 times
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT solution: 300 μL
- Incubation time: 42 hours at 37 ± 1°C, 5 ± 0.5% CO2
- Microplate reader: Versamax® Molecular Devices, Softmax Pro, version 4.7.1
- Wavelength: 570 nm
- Measurement: mean values from the 3 wells per tissue were calculated.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
Positive control
- Viability: 4.64%
- Rel. Standard Deviation: 11.2%
- Range of Viabilities: 4.00% - 5.90%
- Mean Absorption: 0.0803
- Rel. Standard Deviation: 12.6%
- Range of Absorbance: 0.066 - 0.097
Negative control
- Mean Absorption: 1.74
- Rel. Standard Deviation: 8.68%
- Range of Absorbance: 1.48 – 1.98
Data of 31 studies performed from July 2015 until March 2016
NUMBER OF REPLICATE TISSUES: 3
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test item is considered Category 1 or Category 2 (UN GHS published 2003, last (6th) revision 2015) if the mean relative tissue viability of three individual tissues is reduced ≤ 50% of the negative control.
ACCEPTANCE CRITERIA
1. Negative control: The absolute OD 570 nm of the negative control tissues / tissue viability is meeting the acceptance criterion if the mean OD570 of the negative control tissues is ≥ 0.8 and ≤ 2.8.
2. Positive control: An assay is meeting the acceptance criterion if mean relative tissue viability of the positive control is ≤ 20%.
3. Standard deviation: The SD of 3 identical replicates should be < 18%. OD values should not be below historically established boundaries.
Historical data and the quality certificate of the supplier of the test kit demonstrated the robustness of the test system or rather of the test kit. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- undiluted
- Duration of treatment / exposure:
- 60 minutes
- Duration of post-treatment incubation (if applicable):
- 42.75 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 86
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- Prior to use, the test item was melted at 37±2°C for 25 minutes in a water bath and was, subsequently, treated as liquid. The test item passed the MTT- and the colour interference pre-tests.
Treatment with the negative control was well within the required acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for the 60 minutes treatment interval thus showing the quality of the tissues.
Treatment with the positive control induced a decrease in the relative absorbance as compared to the negative control to 4.5% thus ensuring the validity of the test system.
The relative standard deviations between the % variability values of the test item, the positive and negative controls in the main test were below 11%, ensuring the validity of the study.
Any other information on results incl. tables
Results after treatment with the test item and the controls
Dose Group | Tissue | Absorbance 570 nm Well 1 | Absorbance 570 nm Well 2 | Absorbance 570 nm Well 3 | Mean absorbance of 3 Wells | Mean absorbance of 3 Wells blank corrected | Mean absorbance of 3 tissues after blank correction* | Rel. Absorbance (%) Tissue 1,2 and 3* | Realtive Standard Deviation (%) | Mean Rel. Absorbance (% of Negative Control)** | ||
Blank | 0.037 | 0.038 | 0.038 | 0.038 | 0.000 | |||||||
NK | 1 | 1.870 | 1.865 | 1.837 | 1.857 | 1.820 | 1.889 | 96.3 | 3.3 | 100 | ||
2 | 1.954 | 1.947 | 1.944 | 1.948 | 1.911 | 101.1 | ||||||
3 | 1.997 | 1.966 | 1.963 | 1.975 | 1.938 | 102.6 | ||||||
PC | 1 | 0.123 | 0.127 | 0.127 | 0.126 | 0.088 | 0.086 | 4.7 | 6.5 | 4.5 | ||
2 | 0.131 | 0.126 | 0.126 | 0.128 | 0.090 | 4.8 | ||||||
3 | 0.118 | 0.117 | 0.117 | 0.117 | 0.079 | 4.2 | ||||||
TM | 1 | 1.823 | 1.804 | 1.818 | 1.818 | 1.780 | 1.626 | 88.4 | 10.6 | 86 | ||
2 | 1.483 | 1.467 | 1.477 | 1.477 | 1.440 | 94.2 | ||||||
3 | 1.707 | 1.687 | 1.694 | 1.694 | 1.657 | 76.2 |
* relative absorbance per tissue [rounded values]: 100*(absorbance tissue) / (mean absorbance negative control)
** relative absorbance per treatment group [rounded values]: 100*(mean absorbance test item/positive control) / (mean absorbance negative control)
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- Under the experimental conditions reported, the test item is non irritant to skin.
- Executive summary:
In the current study the irritation potential of the test item was assessed in an in vitro study by means of the Human Skin Model Test according to OECD TG 439 and GLP.
The test consists of a topical exposure of the neat test item to a human reconstructed epidermis model followed by a cell viability test. Cell viability is measured by dehydrogenase conversion of MTT [3-(4,5-dimethylthiazole-2-yl)-2,5-diphenyl-tetrazoliumbromide], in mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls is used to predict the skin irritation potential and is used for the purpose of classification as irritating or non-irritating. The test chemical is regarded as skin irritant (UN GHS and EU CLP) if the tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50%. However, a limitation of this test method is the unability to distinguish between Category 1 (skin corrosive) and Category 2 (skin irritant). Thus, a positive result in this assay requires further testing.
The test item did not reduce MTT in the direct MTT reduction pre-test, and did not change the colour in the colour interference pre-test. Also, its intrinsic colour was not intensive. Consequently, additional tests with freeze-killed or viable tissues were not necessary.
Tissues of the human skin model EpiDermTM were treated with the test item, the negative (DPBS) or the positive control (5% SLS) for 60 minutes. The test item, the negative control or the positive control were spread to match the surface of the tissue.
The absorbance values after treatment with the negative control were well within the required range of acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8, assuring the quality of the tissues.
Treatment with the positive control induced a sufficient decrease in the relative absorbance compared to the negative control, assuring the validity of the test system.
After treatment with the test item the mean relative absorbance value decreased to 86.0% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not to be considered to possess irritant potential.
In conclusion, under the experimental conditions reported, the test item is non irritant to skin.
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