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EC number: 800-036-4 | CAS number: 1422423-64-0
- 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:
- January from 21st to 22nd, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
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:
- April 2004
- GLP compliance:
- no
Test material
- Reference substance name:
- Set Retard Plus
- IUPAC Name:
- Set Retard Plus
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: three-dimensional RhE model (EpiDermTM).
- Souce: Mattek (USA)
- Tissue batch number: lot 10810/A.
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during exposure: 37 °C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Number of washing steps: 20 washings using PBS.
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Reagent: 3-[4,5-dimethylthiazol-2yl]-2,5-diphenyl tetrazolium bromide (MTT).
- MTT concentration: 300 µl/plate.
- Incubation time: 3 hours.
- Extraction: isopropanol (2000 µl).
- Wavelength: 550 nm. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 20 mg of test item per unit of epidermis.
- Duration of treatment / exposure:
- 3 minutes and 60 minutes (at 37 °C, 5 % CO2)
- Duration of post-treatment incubation (if applicable):
- 3 hours
- Number of replicates:
- Test material and controls (positive and negative) were applied on each unit of epidermis in duplicate.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Time point: 3 minutes
- Value:
- ca. 105.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Standard deviation: 7.5.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Time point: 60 minutes
- Value:
- ca. 122.5
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Remarks:
- Standard deviation: 26.6.
- Other effects / acceptance of results:
- Classification: non corrosive
Any other information on results incl. tables
RESULTS
SAMPLE |
Mean cell viability (SD)-3 minutes exposure |
Mean cell viability (SD)-60 minutes exposure |
Classification |
SET RETARD PLUS |
105.1 (7.5) |
122.5 (26.6) |
NON CORROSIVE |
KOH 8N |
6.0 (0.6) |
5.8 (1.1) |
CORROSIVE |
NEGATIVE CONTROL |
100.0 (4.8) |
100.0 (2.0) |
-- |
Applicant's summary and conclusion
- Interpretation of results:
- other: non corrosive, i.e. the substance does not meet the criteria to be classified as Skin Corr. 1A/B/C, according to the CLP Regulation
- Conclusions:
- Non corrosive.
- Executive summary:
Method
Corrosion characteristics of test item were evaluated according to the guideline OECD 431 (April 13, 2004), on reconstitued epidermis 3D (EpiDerm™), through MTT test cytotoxicity analysis.
The test item was applied on each epidermis unit in duplicate for 3 minutes and 1 hour at 37°C, 5% CO2. At the end of the exposure, the test item was removed, and cell viability evaluated through MTT test.
Observations
The percentage of mean cell viability for treated cells resulted to be:
- after 3 minutes: 105.1 %
- after 60 minutes: 122.5 %
Results
Non corrosive, i.e. the substance does not meet the criteria to be classified as Skin Corr. 1A/B/C, according to the CLP Regulation
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