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EC number: 219-673-9 | CAS number: 2495-35-4
- 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
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Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- This study was conducted between 11 April 2017 and 11 May 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is considered to be reliability 1 as it has been conducted according to OECD Test Guideline 431 : In vitro Skin Corrosion: Human Skin Model Test and in compliance with GLP.
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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Benzyl acrylate
- EC Number:
- 219-673-9
- EC Name:
- Benzyl acrylate
- Cas Number:
- 2495-35-4
- Molecular formula:
- C10H10O2
- IUPAC Name:
- benzyl acrylate
Constituent 1
- Specific details on test material used for the study:
- Identification: BZA
Chemical Name: Benzyl acrylate
CAS No.: 2495-35-4
Batch: 1B182601
Purity: 99.86%
Appearance: Colorless liquid
Expiry Date: 06 March 2018
Storage Conditions: At room temperature, under protection of sunlight
Stability in Solvent: Not indicated by the Sponsor
Purpose of Use: Industrial chemical
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: The EpiDerm™ tissue consisted of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis
- Source strain:
- not specified
- Details on test system:
- Epi-200 Kit Components Needed for the Assay
EpiDerm™ Kit Lot No.: 25811
1 Sealed 24-well plate Contains 24 inserts with EpiDerm™ tissues on agarose
2 24-well plates For MTT viability assay
4 6-well plates For storing inserts, or for topically applying test agents
1 bottle Serum-Free Assay Medium DMEM-based medium
1 bottle DPBS Rinse Solution For rinsing the inserts in MTT assay
MTT-100 Assay Kit Components
1 vial, 2 mL MTT concentrate
1 vial, 8 mL MTT diluent (supplemented DMEM) For diluting MTT concentrate prior to use in the MTT assay
1 bottle, 60 mL Extractant Solution (Isopropanol) For extraction of formazan crystals - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Test Item Preparation
50 µL (79.4 µL/cm^2 according to guideline) of the test item were dispensed directly onto duplicate EpiDermTM tissue surface - Duration of treatment / exposure:
- 3 minutes and 60 Minutes
- Number of replicates:
- 2, duplicate tissues were treated with: test substance, positive control or negative control.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- other: Relative absorbance
- Run / experiment:
- 3 Minute exposure
- Value:
- 100.4
- Negative controls validity:
- valid
- Remarks:
- Set to 100%
- Positive controls validity:
- valid
- Remarks:
- 21.4
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- other: Relative absorbance
- Run / experiment:
- 1 hour incubation
- Value:
- 89.5
- Negative controls validity:
- valid
- Remarks:
- Set to 100%
- Positive controls validity:
- valid
- Remarks:
- 4.3%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water did not led to a change in colour.
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour
The test item is considered to be non-corrosive to skin:
• since the viability after 3 minutes exposure is greater than 50% and
• the viability after 1 hour exposure is greater than 15%
The acceptance criteria are met:
• the mean OD of the tissue replicates treated with the negative control is ≥ 0.8 and ≤ 2.8 for every exposure time (range: 1.412 to 1.455)
• the mean viability of the tissue replicates treated with the positive control for 1 hour, is <15% compared to the negative control (4.3%)
• the Coefficient of Variation (CV) in the range 20 – 100% viability between tissue replicates is ≤ 30% (range: 1.0% to 9.8%)
Any other information on results incl. tables
Results after treatment with BZA and the controls
Dose Group |
Ex-posure Inter-val |
Absor-bance |
Absor-bance |
Absor-bance |
Mean Absor-bance (Tissue 1/2) |
Mean Ab-sorbance (OD) of 3 Wells minus Blank |
Mean Ab-sorbance (OD) of 2 Tissues |
Absor-bance [% of Negative Control]* |
CV |
Rel. Absor-bance [% of Negative Control]* |
Blank |
|
0.037 |
0.037 |
0.036 |
0.037 |
0.000 |
|
|||
Negative Control |
3 |
1.355 |
1.484 |
1.467 |
1.435 |
1.399 |
1.409 |
99.3 |
1.0 |
100.0 |
1.437 |
1.443 |
1.486 |
1.455 |
1.419 |
100.7 |
|||||
Positive Control |
0.362 |
0.359 |
0.354 |
0.358 |
0.322 |
0.301 |
22.8 |
9.8 |
21.4 |
|
0.316 |
0.312 |
0.322 |
0.317 |
0.280 |
19.9 |
|||||
Test Item |
1.410 |
1.465 |
1.493 |
1.456 |
1.419 |
1.421 |
100.8 |
0.2 |
100.9 |
|
1.455 |
1.463 |
1.462 |
1.460 |
1.424 |
101.1 |
|||||
Blank |
|
0.036 |
0.036 |
0.035 |
0.035 |
0.000 |
|
|||
Negative Control |
1 |
1.467 |
1.448 |
1.441 |
1.452 |
1.417 |
1.397 |
101.4 |
2.0 |
100.0 |
1.405 |
1.428 |
1.403 |
1.412 |
1.377 |
98.6 |
|||||
Positive Control |
0.099 |
0.103 |
0.102 |
0.101 |
0.066 |
0.060 |
4.7 |
13.4 |
4.3 |
|
0.091 |
0.089 |
0.089 |
0.090 |
0.054 |
3.9 |
|||||
Test Item |
1.162 |
1.156 |
1.145 |
1.154 |
1.119 |
1.133 |
80.1 |
1.8 |
81.1 |
|
1.188 |
1.187 |
1.174 |
1.183 |
1.147 |
82.2 |
* relative absorbance [rounded values]:
The optical pre-experiment (colour interference pre-experiment) to investigate the test item’s colour change potential in water did not led to a change in colour.
Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.
The test item is considered to be non-corrosive to skin:
• since the viability after 3 minutes exposure is greater than 50% and
• the viability after 1 hour exposure is greater than 15%
The acceptance criteria are met:
• the mean OD of the tissue replicates treated with the negative control is ≥ 0.8 and ≤ 2.8 for every exposure time (range: 1.412 to 1.455)
• the mean viability of the tissue replicates treated with the positive control for 1 hour, is <15% compared to the negative control (4.3%)
• the Coefficient of Variation (CV) in the range 20 – 100% viability between tissue replicates is ≤ 30% (range: 1.0% to 9.8%)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU CLP and UN GHS
- Conclusions:
- In conclusion, it can be stated that in this study and under the reported experimental conditions, BZA is non corrosive to skin according to EU CLP and UN GHS.
- Executive summary:
This in vitro study was performed to assess the corrosive potential of BZA by means of the Human Skin Model Test with EpiDerm™ tissues models.
The test item did not reduce MTT (test for direct MTT reduction), and it did not change colour, when mixed with deionised water (test for colour interference). Consequently, additional tests with freeze-killed or viable tissues to determine correction factors for calculating the true viability in the main experiment were not necessary.
Independent duplicate tissues of EpiDerm™ were exposed to either the test item, the negative control (deionised water) or the positive control (8.0 N KOH) for 3 minutes and 1 hour, respectively.
After exposure to the negative control the absorbance values met the required acceptability criterion of a mean OD570 ≥ 0.8 and ≤ 2.8 for both treatment intervals thereby confirming the acceptable quality of the tissues.
Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control, both for the 3 minutes exposure period and for the 1 hour exposure period. The 1 hour exposure caused a decrease of the cell viability < 15% of the negative control. The CV in the range 20 – 100% viability between the tissue replicates is ≤ 30%, thus the validity of the test system and the specific batch of the tissue models is confirmed.
After exposure of the tissues to the test item the relative absorbance value did not decrease (100.4%) after 3 minutes exposure. After 1 hour exposure the relative absorbance value was reduced to 89.5%. Both values did not affect the threshold for corrosivity which is defined to be 50% after the 3 minutes exposure and 15% after the 1 hour exposure. Therefore, the test item is not considered to be corrosive.
In conclusion, it can be stated that in this study and under the reported experimental conditions, the test item BZA is non corrosive to skin according to EU CLP and UN GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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