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Diss Factsheets
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EC number: 620-318-9 | CAS number: 1003049-92-0
- 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:
- August 24, 2011 - August 26, 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Skinethic Skin irritation test -42bis Standard operating procedure (SOP) 2009
- Version / remarks:
- 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- barium(2+) strontium(2+) λ¹-europium(1+) silicate
- EC Number:
- 620-318-9
- Cas Number:
- 1003049-92-0
- Molecular formula:
- Ba2-x-ySrxEuySiO4 (0.15
- IUPAC Name:
- barium(2+) strontium(2+) λ¹-europium(1+) silicate
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- To reduce animal testing, this alternative in vitro method was used. The human skin RHE-model 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: SkinEthic™ RHE-model
- Tissue batch number(s): 11 022A 0802
- Date of initiation of testing: August 24, 2011
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: minimum volume of 25 mL PBS using a multi pipette
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/mL
- Incubation time: 3 hours
- Spectrophotometer: spectrophotometer
- Wavelength: 570 nm
NUMBER OF REPLICATE TISSUES:
3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:
One experiment in triplicate
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the viability after exposure is less than 50% or equal to 50 %.
- The test substance is considered to be non-irritant to skin if the viability after exposure is greater than 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 16 mg
NEGATIVE CONTROL
- Amount applied: 16 µL
POSITIVE CONTROL
- Amount applied: 16 µL - Duration of treatment / exposure:
- 42 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 1/experiment 1
- Value:
- 1.681
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 2/experiment 1
- Value:
- 1.79
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Tissue 3/experiment 1
- Value:
- 1.798
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: no
- Direct-MTT reduction: no
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Acceptance criteria met for variability between replicate measurements: Yes
Any other information on results incl. tables
Results
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is to be considered as non-irritating to the skin under the conditions of this experiment.
- Executive summary:
In an in vitro skin irritation model, substance was tested. The applied cellline (RHE (Reconstructed Human Epidermis) is produced by SkinEthic by culturing human adult keratinocytes on a polycarbonate filter in such a quality that a functional stratum corneum is available and thermal differentation takes place. The test was conducted under GLP and according to OECD guideline 439, the EU Method B.46 and the Standard Operating Procedure of SkinEthic's (Skin irritation test -42bis).
Each test is performed in triplicates. 16µl of controls were directly applied to the tissue. Prior 16mg of test substance were applied, 10 µl of water were sprayed to the tissue. After treatment of (treatment time 42minutes at roomtemperature) substances were removed and tissues were incubated for 424 hours.
For testing validity of the Skin model, a positive control (5% sodiumdodecylsulfate in deionized water) and a negative control (PBS buffer) were used.
After topical exposure of test substance, positive control, or negative control cell viability is measured in a MTT assay. In this assay cell viability is measured by conversion of MTT to a formazan salt by a dehydrogenase enzyme.
As the test item has a very high cell viability of (100%) passing the threshold value of 50%, this item is to be considered as non-irritant. The test is valid since the criteria for the positive control (cell viability < 40%; 3,1% in this test) and the negative control (optical density between 1.2 and 2.5; 1.75 in this itest) are met.
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