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EC number: 227-615-9 | CAS number: 5908-81-6
- 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 irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 3, 2014 - November 7, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- (2013)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.40 BIS (In Vitro Skin Corrosion: Human Skin Model Test)(2008)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Barium tartrate
- EC Number:
- 227-615-9
- EC Name:
- Barium tartrate
- Cas Number:
- 5908-81-6
- Molecular formula:
- C4H4O6Ba
- IUPAC Name:
- Barium L(+)-(2R,3R)-tartrate
- Details on test material:
- - Name of test material (as cited in study report): Barium tartrate
- Appearance: White powder
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- All incubations, with the exception of the test substance incubation of 3 minutes at room temperature, were carried out in a controlled environment, in which optimal conditions were a humid atmosphere of 80 - 100% (actual range 80 - 88%), containing 5.0 ± 0.5% CO2 in air in the dark at 37.0 ± 1.0°C (actual range 36.6 - 36.7°C).
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 25 mg
- The test material was spread to match the size of the tissue
NEGATIVE CONTROL
- Amount applied: 50 µL Milli-Q water (Millipore Corp., Bedford, Mass., USA)
POSITIVE CONTROL
- Amount applied: 50 µL KOH (Merck, Darmstadt, Germany)
- Concentration (if solution): 8N - Duration of treatment / exposure:
- - 3 minutes
- 1 hour - Details on study design:
- TEST FOR REDUCTION OF MTT
The test substance was checked for possible direct MTT reduction before the study was started. To assess the ability of the test substance to reduce MTT, 118.8 mg of the test substance was added to 1.2 mL MTT medium. The mixture was incubated for approximately 1 hour at 37.0 ± 1.0°C. A negative control, sterile Milli-Q water was tested concurrently.
APPLICATION/TREATMENT
The test was performed on a total of 4 tissues per test substance together with a negative control and positive control. Two tissues were used for a 3-minute exposure to the test substance and two for a 1-hour exposure. The skin was moistened with 25 µL Milli-Q water (Millipore Corp., Bedford, Mass., USA) to ensure close contact of the test substance to the tissue and 25 mg of the solid test substance (glass weight boat) was added into the 6-well plates on top of the skin tissues. The remaining tissues were treated with 50 µL Milli-Q water (negative control) and with 50 µL 8N KOH (positive control), respectively.
REMOVAL OF TEST SUBSTANCE
- Washing: phosphate buffered saline (Invitrogen Corporation, Breda, The Netherlands)
- Time after start of exposure: 3 minutes and 1 hour
- Rinsed tissues were kept in 24 well plates on 300 µL DMEM medium until 6 tissues (= one application time) were dosed and rinsed.
SCORING SYSTEM
- Percentage viability. Cell viability was calculated for each tissue as percentage of the mean of the negative control tissues. Skin corrosion potential of the test substance was classified according to remaining cell viability following exposure of the test substance with either of the two exposure times.
- The DMEM medium was replaced by 300 µL MTT-medium and tissues were incubated for 3 hours at 37°C in air containing 5% CO2. After incubation the tissues were washed with PBS and formazan was extracted with 2 mL isopropanol (MatTek corporation) over night at room temperature. The amount of extracted formazan was determined spectrophotometrically at 540 nm in triplicate with the TECAN Infinite® M200 Pro Plate Reader.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Percentage viability
- Basis:
- other: Percentage of control
- Time point:
- other: 3 minutes
- Score:
- 91
- Remarks on result:
- other: Negative control: 100%; Positive control: 11%
- Irritation parameter:
- other: Percentage viability
- Basis:
- other: Percentage of control
- Time point:
- other: 1 hour
- Score:
- 92
- Remarks on result:
- other: Negative control: 100%; Positive control: 7%
Any other information on results incl. tables
- Mean absorption (duplicate exposures are indicated by A and B):
|
3-minute application |
1-hour application |
||||||||
A (OD540) |
B (OD540) |
Mean (OD540) |
SD |
A (OD540) |
B (OD540) |
Mean (OD540) |
SD |
|||
Negative control |
1.642 |
1.620 |
1.631 |
± |
0.015 |
1.533 |
1.515 |
1.524 |
± |
0.013 |
Barium tartrate |
1.518 |
1.444 |
1.481 |
± |
0.052 |
1.310 |
1.503 |
1.406 |
± |
0.136 |
Positive control |
0.198 |
0.146 |
0.172 |
± |
0.036 |
0.112 |
0.098 |
0.105 |
± |
0.010 |
SD = Standard deviation
In this table the values are corrected for background absorption (0.042). Isopropanol was used to measure the background absorption.
- Barium tartrate was checked for possible direct MTT reduction by adding the test substance to MTT medium. Because no colour change was observed it was concluded that Barium tartrate did not interact with MTT.
- Mean tissue viability:
|
3-minute application viability (percentage of control) |
1-hour application viability (percentage of control) |
Negative control |
100 |
100 |
Barium tartrate |
91 |
92 |
Positive control |
11 |
7 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In an in vitro skin corrosion test using a human three dimensional epidermal model, conducted according to OECD 431 and GLP principles, it was determined that the substance is not corrosive to skin.
- Executive summary:
In an in vitro skin corrosion test using a human three dimensional epidermal model (EpiDerm (EPI-200)), conducted according to OECD 431 and GLP principles, the possible corrosive potential of the substance was tested through topical application for 3 minutes and 1 hour. Reliable negative and positive controls were included. Skin tissue was moistened with 25 µL of Milli-Q water and 25 mg of the substance was applied directly on top of the skin tissue. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the substance compared to the negative control tissues was 91% and 92%, respectively. Because the mean relative tissue viability was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment, the substance is considered to be not corrosive to skin.
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