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EC number: 210-668-7 | CAS number: 621-08-9
- 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:
- 8.12.2015 - 11.12.2015
- 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:
- Adopted: 28th July, 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- Commission Regulation (EC) No. 761/2009, 23rd July 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Protocol for: INVITRO EpiDermTM SKIN IRRITATION TEST For use with MatTek Corporation’s Reconstructed Human Epidermal Model EpiDerm
- Version / remarks:
- Model EPI-200-SIT, Rev. 26/3/2012,1-37
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dibenzyl sulphoxide
- EC Number:
- 210-668-7
- EC Name:
- Dibenzyl sulphoxide
- Cas Number:
- 621-08-9
- Molecular formula:
- C14H14OS
- IUPAC Name:
- (phenylmethanesulfinylmethyl)benzene
- Test material form:
- solid: particulate/powder
- Details on test material:
- - State of aggregation:
- Particle size distribution:
- Mass median aerodynamic diameter (MMAD):
- Geometric standard deviation (GSD):
- Shape of particles:
- Surface area of particles:
- Crystal structure:
- Coating:
- Surface properties:
- Density:
- Moisture content:
- Residual solvent:
- Activation:
- Stabilisation:
- Other:
White solid powder
Storage: The test substance was stored in dry room in dark in closed container at the room temperature.
Content of water: 0.025 % w/w (volumetric Karl Fischer titration)
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: tissue for research puposes from accredited institutions
- Source strain:
- other: Keratinocyte strain 00267
- Vehicle:
- water
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
tissues: the reconstructed human epidermal model EpiDerm (EPI-200 ver. 2.0, MatTek, Bratislava, SK); Lot No. 23306
Certificate of analysis 9.12.2015
TEMPERATURE USED FOR TEST SYSTEM
culture conditions 37±1°C, 5±1 % CO2, moistened tissue
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume and number of washing steps: thoroughly rinsed with PBS, blotted to remove the test substance
After exposition the test substance was removed, tissues were rinsed and post-incubated. Small amount (a few points) of the test substance remained in tissues after washing.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg·mL-1
- Incubation time: 3 h
- Spectrophotometer: Libra S22 at 570 nm. Isopropyl alcohol serves as a blank.
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
Based on Certificate of Analysis the model passed all parametres for viability, barrier function, sterility.
NUMBER OF REPLICATE TISSUES: 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
1. Direct MTT reduction - functional check in tubes
2. MTT test
PREDICTION MODEL / DECISION CRITERIA
OECD Test Guideline No. 439 (1), par. 36:
- In case the test chemical is found to be non-corrosive (e.g., based on TG 430, 431 or 435), and shows tissue viability after exposure and post-treatment incubation is less than or equal (≤) to 50%, the test chemical is considered to be irritant to skin in accordance with UN GHS (3) Category 2.
- The test chemical may be considered as non-irritant to skin in accordance with UN GHS No Category if the tissue viability after exposure and post-treatment incubation is more than (>) 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of the test substance was placed directly atop the tissue previously moistened with 25 µL of PBS and it was layed such, that the test substance covered its entire surface.
NC: PBS (phosphate buffered saline), prepared 11/11/2015, exp. 11/05/2016 and 27/10/2015, exp. 27/04/2016
PC: 5 % SDS (sodium dodecyl sulphate), MatTek, Lot No. 020615TMH, exp. 06/02/2016 - Duration of treatment / exposure:
- 1 hour
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 96.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- All study acceptance criteria were fulfilled.
The mean OD570 of the NC tissue was 1.924 ±0.044 which meets the acceptance criteria of ≥ 0.8 and ≤ 2.8.
The mean viability of the PC tissues expressed as % of the negative control tissues is 3.5% which meets the acceptance criterion of ≤ 20 %.
The SD calculated from individual % tissue viabilities of the 3 identically treated replicates for the positive control, negative control and test substance was < 18 %.
Any other information on results incl. tables
MTT test
OD570values obtained at the MTT test, their averages, standard deviations (%) and relative viabilities
Treatment |
OD570 |
|
|
Mean |
SD |
%NC |
PBS (NC) |
1.984 |
1.910 |
1.879 |
1.924 |
0.044 |
|
viability (%NC) |
103.1 |
99.3 |
97.6 |
100.0 |
2.3 |
100.0 |
480/15 (DBSO) |
1.787 |
1.808 |
1.958 |
1.851 |
0.076 |
|
viability (%NC) |
92.9 |
94.0 |
101.7 |
96.2 |
4.0 |
96.2 |
5% SDS (PC) |
0.056 |
0.077 |
0.070 |
0.068 |
0.009 |
|
viability (%NC) |
2.9 |
4.0 |
3.6 |
3.5 |
0.5 |
3.5 |
PBS - phosphate buffered saline
DBSO - Dibenzylsulfoxide
SDS - sodium dodecyl sulphate
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the above-described experimental design, average viability of tissues treated by the test substance was 96.2 %, i.e.viability was > 50 %.
The effect of the test substance was negative in EpiDermTM model (the tissue was not damaged).
According to the classification criteria the test substance is considered to have no category in regard to skin irritation. - Executive summary:
Test substance, Dibenzylsulfoxide, was assayed for the in vitro skin irritation in human epidermal model EpiDermTM. The test was performed in compliance with european legislation (see Material and methods)
After pre-incubation of tissues, 25 mg of the test substance was placed directly atop to the previously moistened tissue so it covered all tissue surfaces. Length of exposition was 60 minutes. Three tissues were used for the test substance and for every control.
After removal of the test substance from tissues, tissues were post incubated for 42 hours due to leave of damage reparation. Three hours incubation with MTT and two hours extraction period with shaking followed then. Optical density (OD570) 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.
Under the above-described experimental design, average viability of tissues treated by the test substance was 96.2 %, i.e.viability was > 50 %.
The effect of the test substance was negative in EpiDermTM model (the tissue was not damaged).
According to the classification criteria the test substance is considered to have no category in regard to skin irritation.
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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