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Diss Factsheets
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EC number: 934-407-8 | CAS number: -
- 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:
- 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
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Method B.40 bis In vitro skin corrosion: human skin model test (Annex to Regulation (EC) No 440/2008)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- solid: flakes
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:040801#
- Expiration date of the lot/batch: 05.08.2016
- Purity test date:07/10/2015
- purity: 91.61%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: stable in water, instable after repeated contact to air
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: moistened with 100 +/- 5 µl of 0.9% NaCl solution, to ensure good contact surface.
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Episkin Small Model
- Source strain:
- not specified
- Details on animal used as source of test system:
- Not applicable
- Justification for test system used:
- This test uses the EPISKIN-SM™ reconstructed human epidermis model (SkinEthic) which consists of normal human epidermal keratinocytes (NHEK) and therefore represents in vitro the target organ of the species of interest and closely mimics the biochemical and physiological properties of the upper parts of the human skin, i.e. the epidermis.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPISKIN-SM (SkinEthic)
- Tissue batch number(s): 16-EKIN-002
- Production date: 12/01/2016
- Shipping date: 12/01/2016
- Delivery date: 12/01/2016
- Experimental starting date: 13/01/2016
- Expiration date: 18/01/2016
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation (if applicable): 37 +/-1°C (3 hours MTT incubation)
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: 25 ml PBS, 15 times
- Observable damage in the tissue due to washing :
- Modifications to validated SOP: none
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 3 mg/ml MTT in PBS (stock solution) / 0.3 mg/ml (1:9 DMEM-based medium (MTT medium)
- Incubation time: 3 hours
- Spectrophotometer: Plate spectrophotometer
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: absolute OD570 for blank was 0.042 (mean of 2 aliquots) for these experiment.
historical data absolute OD570 for blank was 0.044 (SD 0.002 / n=21) / Relative viability PC = 5.0 % (SD 1.9, n=21) and a maximal difference viability of 8% (SD = 7.4, n=197). Historical control data were generated in 2014-2015.
- Barrier function: IC50 = 2mg/ml (SDS concentration, MTT test, n=14 – specification ≥ 1.5 mg/ml)
- Morphology: histology scoring = 21.8 +/- 0.3, CV = 1.3% (HSE stained vertical paraffin sections, n=6 – specification ≥ 19.5)
- Contamination: Free of bacteria, fungus and mycoplasma
NUMBER OF REPLICATE TISSUES: each dose group in duplicate (6 tissues/test item)
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
No MTT direct interference notified
- Fresh tissues / killed tissues
- Procedure used to prepare the killed tissues (if applicable):
- N. of replicates :
- Method of calculation used:
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 35%, or if the viability after 3 minutes exposure is greater than or equal to 35 % and the viability after 60 min exposure is less than 35% or if the viability after 60 minutes exposure is greater or equal to 35% and the viability after 4 hours exposure is less than 35%.]
- The test substance is considered to be non-corrosive to skin if the viability after 4 hours treatment is greater than or equal to 35% - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):20 mg + 100 µl 0.9% NaCl solution
NEGATIVE CONTROL
- Amount(s) applied (volume or weight):50 µl
- Concentration (if solution): 0.9%
POSITIVE CONTROL
- Amount(s) applied (volume or weight):50µl - Duration of treatment / exposure:
- 3 minutes / 60 minutes / 4 hours
- Duration of post-treatment incubation (if applicable):
- 3 hours in MTT medium
- Number of replicates:
- Test item: 2 for each times of exposure
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean relative value
- Run / experiment:
- 3 min
- Value:
- ca. 96
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean relative value
- Run / experiment:
- 60 min
- Value:
- ca. 103
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not examined
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean relative value
- Run / experiment:
- 4 hours
- Value:
- ca. 112
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- mean relative tissue viability of 3%
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
- Colour interference with MTT: no
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control:Yes (Mean Absolute OD(570 nm), 3 min exp. = 0.885, Mean Absolute OD(570 nm), 60 min exp. = 0.865, Mean Absolute OD(570 nm), 4 hours exp. = 0.774). Mean absolute OD (570 nm) of the two negative control tissues of every treatment period is between 0.6 and 1.5
- Acceptance criteria met for positive control:Yes (4h exp. : 3%). Mean relative tissue viability of the 2 positive control tissues of the 4 hours treatment period is less or equal to 20%
- Acceptance criteria met for variability between replicate measurements:Yes (value 0.2 - 11.5%). In the range of 20-100% viability and for ODs superior to 0.3, the difference between each two replicates must be less or equal to 30%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the in vitro skin corrosion test on a human skin model (EPISKIN-SM), following the EC guideline Method B.40 BIS, the test substance is classified as no-corrosive.
- Executive summary:
The potential of the test item to induce skin corrosion was analysed by using the three-dimensional human skin model EPISKIN-SM™, comprising a reconstructed epidermis with a functional stratum corneum. In the present study the substance was applied topically to the EPISKIN-SM™ tissue for 3 min, 60 min and 4 h followed by immediate determination of cytotoxic effects via MTT reduction assay. Corrosivity potential of the test item was predicted from the relative mean tissue viabilities compared to the corresponding negative control tissues concurrently treated with 0.9% NaCl. The test item showed no non-specific MTT-reducing or water-colouring potential. The test item is no MTT-reducer and has no coloring potential, therefore no additional controls were necessary. The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was ≥ 35% (112%) after 4 h treatment. Relative mean tissue viability was 103% after 60 min treatment and 96% after 3 min treatment. The controls confirmed the validity of the study. The mean OD (570 nm) of the two negative control tissues was between 0.6 and 1.5 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was ≤ 20% (3%) after 4 h treatment. The maximum inter tissue viability difference of replicate tissues of all dose groups was ≤ 30% (0.2% - 11.5%).
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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