Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 246-562-2 | CAS number: 25013-15-4
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 October 2020 - 16 December 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EC method B.40 bis: In vitro Skin Corrosion: Human Skin Model Test Council Regulation (EC) No. 2019/1390, adopted 31 July 2019.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-methylstyrene
- EC Number:
- 202-889-2
- EC Name:
- 3-methylstyrene
- Cas Number:
- 100-80-1
- Molecular formula:
- C9H10
- IUPAC Name:
- 1-methyl-3-vinylbenzene
- Reference substance name:
- 4-methylstyrene
- EC Number:
- 210-762-8
- EC Name:
- 4-methylstyrene
- Cas Number:
- 622-97-9
- Molecular formula:
- C9H10
- IUPAC Name:
- 1-methyl-4-vinylbenzene
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Provided by Sponsor, Batch no.: 20200608
- Expiration: 07 June 2021
- Purity, including information on contaminants, isomers, etc.: 99.66% (3-Vinyltoluene CAS No. 100-80-1: 64.3 %; 4-Vinyltoluene CAS No. 622-97-9: 35.7 %)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Stored at +2 °C to +8 °C in a tightly closed container
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): none, the test item was used as supplied.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm™
- Tissue batch number(s):Lot no. 30897
- Production date: October 14,2020
- Date of initiation of testing: October 13,2020
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37℃
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 18 times in approximately 100 mL D-PBS
- Observable damage in the tissue due to washing: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: Tecan infinite 200Pro10
- Wavelength: 540 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: OD[540-570nm] (1.0-3.0):1.906±0.071
- Barrier function: ET-50[4.77-8.72 hrs]:6.52 hrs
- Contamination: Sterile
NUMBER OF REPLICATE TISSUES:
Two tissues were used per treatment for test item, positive and negative controls.
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE/COLOUR INTERFERENCE
1. Functional check for MTT interference was performed as follows: Fifty μL of the test item were added to 1 mL of the MTT medium (1 mg MTT6/mL) and incubated at 37 °C, 5 % CO2, and 95 % relative humidity for 60 minutes. Untreated MTT solution was used as control. The test item displayed a slight purple discolouration. Due to interacting of the test item with the MTT measurement (reduction of MTT) an additional test with freeze-killed tissues had to be performed. The frozen tissues were stored in the freezer (-20 ± 5 °C). The test item was applied to two freeze-killed tissues9. In addition, two freeze-killed tissues were treated with the negative control. The entire assay protocol was performed on the frozen tissues in parallel to the assay performed with the live EpiDermTM tissues.
2. Functional check for colour interference was performed as follows: Fifty μL of the test item were mixed with 300 μL sterile deionised water and incubated at 37 °C, 5 % CO2 and 95 % relative humidity for 60 minutes. In addition, 50 μL of the test item were added to 2 mL isopropanol and incubated at room temperature for three hours. No discolouration of the test item was observed in either case.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be non-corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.] - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Fifty µL
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): Fifty µL
POSITIVE CONTROL
- Amount(s) applied (volume or weight): Fifty µL
- Concentration (if solution): 8 N - Duration of treatment / exposure:
- 3 minutes and 60 minutes
- Number of replicates:
- 2
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 mins
- Value:
- 85.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: 85.4 % ± 3.7
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: none
- Direct-MTT reduction and Colour interference with MTT: No discolouration of the test item with water or isopropanol was noted.
As the test item displayed a slight purple discolouration due to interaction of the test item with the MTT measurement (reduction of MTT), an additional test with freeze-killed tissues had to be performed. The OD correction factor for the 3-minute exposure was 0.0034, while the OD correction factor for the 1-hour exposure was determined as 0.0295.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control and positive control:
The mean optical density (OD) of the negative control of 2 tissues was 1.7940 (3-minute exposure) or 1.7560 (1-hour exposure) and was well within the acceptable range of ≥ 0.8 to ≤ 2.8.
The mean viability of cells treated with the positive reference item 8 N KOH was 6.7 % ± 0.1 % or 4.0 % ± 0.2 % (3-minute or 1-hour exposure, respectively) of the negative control and, hence well below the 15 % cut-off value at the 1-hour exposure.
- Acceptance criteria met for variability between replicate measurements:
The difference of viability between two tissue replicates (for tissues in the viability range between 20 – 100 % viability) was below the limit of acceptance of 30 %. Hence, all acceptance criteria were fulfilled
Historical data of negative and positive controls are presented in Appendix 3.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the in vitro skin corrosion test using the reconstructed human epidermal model EpiDerm, the test item Vinyltoluene was non-corrosive.
- Executive summary:
In an in vitro skin corrosion in the human epidermal model EpiDerm (OECD 431/GLP), reconstructed human epidermis tissue was exposed to 50 µL of Vinyltoluene (99.66%; 3-Vinyltoluene CAS No. 100-80-1: 64.3 %; 4-Vinyltoluene CAS No. 622-97-9: 35.7 %) for 3 and 60 minutes. Sterile deionised water was used for the negative control and 8N KOH was used for the positive control. After removal of the test substance, the tissues were incubated with MTT for three hours and then extracted with isopropyl alcohol overnight at room temperature with shaking. The OD540 of isopropyl alcohol extracts was measured on a spectrophotometer. Relative cell viability was calculated for each tissue as % of the mean viability of the negative control tissues.
The controls confirmed the validity of the study. The mean absolute OD570 of the 2 negative control tissues was ≥ 0.8 and ≤ 2.8 [1.7940 (3 min) and 1.7560 (60 mins)]. The mean relative tissue viability (% negative control) of the positive control was < 15% [6.7 % ± 0.1 % or 4.0 % ± 0.2 % (3-minute or 60 mins exposure, respectively)]. The colour of the test substance did not interfere with the endpoint. As the test item displayed a slight purple discolouration due to interaction of the test item with the MTT measurement (reduction of MTT), an additional test with freeze-killed tissues had to be performed. The OD correction factor for the 3-minute exposure was 0.0034, while the OD correction factor for the 1-hour exposure was determined as 0.0295.The average viability of tissues treated by the test item, 1 Vinyltoluene were higher than the threshold values (50 % and 15% respectively): 85.4 % ± 3.7 after a 3-minute exposure period and 63.5 % ± 2.7 after a 1-hour exposure. The test item should be regarded as non-corrosive.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
За да гарантираме, че се възползвате максимално от функциите на нашия уебсайт, сме въвели „бисквитки“.