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EC number: 243-478-8 | CAS number: 20039-37-6
- 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:
- August - November 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- 13 April 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pyridinium dichromate
- EC Number:
- 243-478-8
- EC Name:
- Pyridinium dichromate
- Cas Number:
- 20039-37-6
- Molecular formula:
- C5H5N.1/2Cr2H2O7
- IUPAC Name:
- pyridinium dichromate
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: MatTek´s EpiDerm System consists of normal, human-derived epidermal keratinocytes which have been cultured form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm™ tissues (surface 0.6 cm²) are cultured on specially prepared cell culture inserts (MILLICELLs, 10 mm ) and shipped as kits, containing 24 tissues on shipping agarose.
REMOVAL OF TEST MATERIAL AND CONTROLS
- washing with PBS
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
After incubation with the test substance and washing with PBS, the tissues were incubated with MTT medium at 37 °C and 5 % CO2. After 3 hours, the MTT medium was aspirated from all wells and the tissues were gently rinsed with PBS (2 times). For extraction, the tissues were incubated with extractant solution (isopropanol) for 2 hours with shaking. After the extraction period, the tissues were pierced with an injection needle and the extract (now a blue formazan solution) was allowed to run into the well from which the tissue was taken. The 24-well plates were placed on a shaker for 15 minutes until the solutions were homogeneous in colour. For the Epiderm Skin Corrosivity Test per each tissue 3 × 200 μL aliquots of the blue formazan solution were transferred into a 96-well flat bottom microtiter plate and the OD was measured using the extractant solution as blank in a plate spectrophotometer at 570 nm, without reference filter.
- Incubation time: 3 h at at 37 °C and 5 % CO2
- Wavelength: 570 nm
Cell viability
Cell viability was calculated for each tissue as percent of the mean of the negative control tissues. The skin corrosivity/irritation potential of the test substance was classified according to remaining cell viability obtained after test substance treatment with either of the two exposure times.
NUMBER OF REPLICATE TISSUES:
Two tissue replicates were used for each treatment (exposure time), including distilled water as negative and 8N KOH as positive control.
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15 %.
- The test substance is considered to be non-corrosive to skin if 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:
The application spoon was filled with 25 mg finely grounded test substance. The "spoonful" was levelled by gently scratching the excess material away, avoiding compression. 25 µL H2O were added for wetting of the test substance.
NEGATIVE CONTROL
- Amount(s) applied: 50 µL
POSITIVE CONTROL
- Amount(s) applied: 50 µL - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1st (3 min exposure)
- Value:
- 75.5
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 15.1%
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1st (1 hour expoure)
- Value:
- 1
- Negative controls validity:
- valid
- Remarks:
- 100%
- Positive controls validity:
- valid
- Remarks:
- 10.7%
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- According to the results of this study, the test substance is considered to be corrosive to skin.
- Executive summary:
The EpiDerm Skin Corrosivity/Irritation Test (Model EPI-200) was performed to reveal possible irreversible tissue damages of the skin following the application of the test substance.
The test substance (50 µL) was topically applied for 3 minutes and 1 hour to the epidermal surfaces of three-dimensional human epidermis models, followed by immediate determination of the cytotoxic effect. Two tissue replicates were used for each treatment (exposure time), including deionised water as negative and 8N KOH as positive control. Investigations performed were in conformance with the Regulation (EC) 440/2008: B.40.BIS. "In vitro skin corrosion: human skin model" and the OECD-Guideline 431 "In Vitro Skin Corrosion: Human Skin Model Test ".
Results:
The mean percentage viability of the test item-treated skin discs after 3 minutes of exposure was 75.5 % which is above the threshold of 50 % for classification. The mean percentage viability of the test–item treated skin discs after 1 hour of exposure was 1.0 % which is below the threshold of 15 % for classification.
Conclucion:
According to the results of this study, the test substance is considered to be corrosive to skin.
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