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EC number: 222-357-3 | CAS number: 3444-17-5
- 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:
- 2017-01-10 to 2017-03-31
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- Version / remarks:
- dated 29 July 2016
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Test method B.40bis Council regulation n°440/2008
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 23 October 2015
Test material
- Reference substance name:
- Chromium tris((2-ethylhexanoate)
- EC Number:
- 222-357-3
- EC Name:
- Chromium tris((2-ethylhexanoate)
- Cas Number:
- 3444-17-5
- Molecular formula:
- Cr(C8H16O2)3
- IUPAC Name:
- chromium(3+); 2-ethylhexanoate
- Test material form:
- other: Solid/paste
Constituent 1
In vitro test system
- Test system:
- human skin model
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The 0.6 cm² reconstructed epidermis (epiCS, Cell Systems - batch n° 100-AF2446-1) were received on 17 January 2017. The insert (filter + epidermis) was gently removed from the agarose while avoiding leaving agarose on the polycarbonate filter. The insert was placed in a 6 wells culture plate which had been previously filled with 1 mL of culture medium (Cell Systems batch n° 305-AG0224). The culture dishes were incubated at 37 +/- 2°C, 5% CO2 during 20 hours and 45 minutes before treatment. Just before the treatment, the culture medium was replaced by a new culture medium (Cell Systems, batch n° 305-AG0224).
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
- Amount/concentration applied:
- The test item was applied, as supplied,after being applied on a nylon mesh, at the dose of 25 mg,during 3 minutes and during 1 hour at room temperature, to the epidermal surface of 4 living human skin models, including two for the non-specific colour (NSC) control.
In the same experimental conditions, a positive control (8N KOH - Sigma batch n° SLB3295V) and a negative control (DPBS - PAN BIOTECH GmbH, batch 9510916) were carried out. - Duration of treatment / exposure:
- 3 minutes and 1 hour
- Number of replicates:
- 4 living human skin models (2 living for non-specific colour living control)
Test system
- Details on study design:
- 3 minutes and 1 hour after the test item applicationn, the human epidermis was washed 20 times with 1 mL of DPBS (PAN BIOTECH GmbH, batch n° 9510916). The rinsed tissues were checked for coloration and presented green spots.
The cell viability was quatified by measurement of the cell succinate dehydrogenase activity. This enzyme was responsible for the MTT [3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazol blue; CAS n° 298-93-1] reduction into blue formazan crystal. The skin sample was placed in MTT solution of 1 mg/L concentration, except for the two tissues for the non-specific control which were placed in MTT assay medium (Cell Systems batch n° 303-AG0224), for 3 hours between 36.8°C and 37.8°C, 5% CO2. The precipitated blue formazan product was then extracted using isopropanol during 2 hours under agitation in the dark, and the concentration of formazan was measured by determining the Optical Density (OD) at 570 nm, just after dilution of the extraction in isopropanol (1:3).
The absorbance was measured in triplicate of MTT extract.
The measured absorbances were proportional to the number of living cells.
The measurement of OD was performed using the Elx800 absorbance microplate reader (controlled and calibrated every year if necessary) supplied by BioTek and the validated software Gen5 ELISA V1.05.11 supplied by BioTek.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes after the test item application
- Value:
- 78.19
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour after the test item application
- Value:
- 84.55
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The results are expressed as a viability percentage compared with the negative control:
viability % = OD test item / OD negative control x 100
Because the test item was potentially causing colour interferences, true viability was calculated as follows:
true viability % = [(OD of living tissues exposed to test item - OD of living tissues exposed to test item incubated with medium without MTT) / OD of living tissues exposed to negative control] x 100
Any other information on results incl. tables
The mean viability of epidermis skins treated with the positive control item (potassium hydroxide 8N) was 58.81% and 0.74% respectively 3 minutes and 1 hour after the application.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with Regulation EC 1272/2008, the results obtained under these experimental conditions unable to conclude that the test item does not have to be classified in category 1 'Corrosive'.
The hazard statement 'H314: Causes severe skin burns and eye damage' with the signal word 'Danger' are not required.
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